Orajel and pregnancy. Orajel During Pregnancy: Safety, Usage, and Precautions for Dental Pain Relief
Is Orajel safe to use during pregnancy. What are the risks and benefits of using Orajel for dental pain while pregnant. How should pregnant women use Orajel safely. What are the alternatives to Orajel for dental pain relief during pregnancy.
Understanding Orajel: Composition and Intended Use
Orajel Dental Gel is a widely used over-the-counter medication designed to provide temporary relief from toothache pain. The active ingredient in Orajel is benzocaine, a local anesthetic that works by numbing the affected area. Specifically, Orajel contains 10% w/w benzocaine, making it a potent solution for dental discomfort.
The primary therapeutic indication for Orajel is the rapid, short-term relief of toothache pain associated with open carious lesions and direct exposure of vital dental pulp. This makes it a go-to solution for many individuals experiencing dental pain, particularly when immediate dental care is not available.
How does Orajel work?
Benzocaine, the active ingredient in Orajel, belongs to the ester type of local anesthetics. It works by temporarily blocking nerve signals in the area where it’s applied. This action results in a reversible loss of sensation, effectively numbing the painful area and providing relief from toothache.
Orajel Usage Guidelines and Precautions
While Orajel can be an effective solution for dental pain, it’s crucial to use it correctly and be aware of potential risks and precautions. Here are the key points to consider:
- Orajel is intended for adults and children aged 12 years and over.
- Apply a pea-sized amount of gel to the affected area using a clean finger or swab.
- Use up to 4 times daily, but avoid continuous use.
- If toothache persists, consult a dentist.
- Not recommended for children under 12 years of age.
It’s important to note that Orajel is meant for short-term use until professional dental care can be obtained. Prolonged or excessive use may lead to complications.
Are there any contraindications for using Orajel?
Yes, there are several contraindications to be aware of when considering the use of Orajel:
- Known sensitivity to benzocaine or any other ingredients in the product
- Individuals suspected of lacking the ability to convert methemoglobin to hemoglobin
- Children under 12 years of age
- Family history of methemoglobinemia
Orajel and Pregnancy: Safety Considerations
The use of Orajel during pregnancy is a topic of particular concern for many expectant mothers dealing with dental pain. While benzocaine has been widely used for many years without apparent ill consequences, there is inadequate evidence of its safety in human pregnancy.
The Summary of Product Characteristics (SmPC) for Orajel states that no clinical data are available on the use of this product during pregnancy and lactation. This lack of definitive data means that pregnant women should exercise caution and consult with their healthcare provider before using Orajel.
What are the potential risks of using Orajel during pregnancy?
While specific risks related to pregnancy are not clearly defined, there are general risks associated with the use of benzocaine that pregnant women should be aware of:
- Hypersensitivity reactions (burning, stinging, itching, rash)
- Contact dermatitis
- Methemoglobinemia (a rare but serious blood disorder)
These risks, while not specific to pregnancy, could potentially have more severe consequences for pregnant women or their developing fetuses. Therefore, it’s crucial to weigh the benefits of pain relief against these potential risks.
Alternatives to Orajel for Dental Pain During Pregnancy
Given the uncertainty surrounding the use of Orajel during pregnancy, many expectant mothers may seek alternative methods for managing dental pain. Here are some potential options:
- Saltwater rinses: A simple and safe method to reduce inflammation and provide temporary relief.
- Clove oil: A natural alternative with analgesic properties, though it should be used sparingly and with caution.
- Cold compress: Applying a cold pack to the outside of the cheek can help numb pain and reduce swelling.
- Acetaminophen: Generally considered safe during pregnancy, but should be used under a doctor’s guidance.
- Professional dental care: Addressing the underlying cause of the pain is often the best long-term solution.
It’s important to note that while these alternatives may provide relief, they are not substitutes for professional dental care. Pregnant women experiencing persistent dental pain should consult with their dentist or obstetrician for appropriate treatment options.
Potential Side Effects and Adverse Reactions to Orajel
While Orajel can be effective for temporary pain relief, it’s important to be aware of potential side effects and adverse reactions. These can occur in both pregnant and non-pregnant individuals:
- Burning or stinging sensation at the application site
- Itching or rash
- Swelling or edema
- Contact dermatitis
- In rare cases, methemoglobinemia (especially in infants and young children)
If any of these symptoms persist or worsen, or if they are accompanied by fever, headache, breathlessness, nausea, or vomiting, it’s crucial to seek medical attention immediately.
What is methemoglobinemia and why is it a concern with Orajel use?
Methemoglobinemia is a rare but serious blood disorder where an abnormal amount of methemoglobin is produced in the blood. This condition can result in reduced oxygen delivery to tissues, leading to symptoms such as pale, gray, or blue-colored skin, shortness of breath, fatigue, and in severe cases, life-threatening complications.
While rare, methemoglobinemia has been associated with the use of benzocaine products like Orajel, particularly in infants and young children. This is one of the reasons why Orajel is not recommended for children under 12 years of age and why caution is advised for its use during pregnancy.
Interactions of Orajel with Other Medications
When considering the use of Orajel, especially during pregnancy, it’s crucial to be aware of potential interactions with other medications. The primary interaction of concern is with sulfonamides:
- Benzocaine, like other derivatives of para-aminobenzoic acid, inhibits the actions of sulfonamides.
- Therefore, Orajel should not be used concomitantly with any sulfonamide medications.
This interaction is particularly important for pregnant women who may be taking sulfonamide antibiotics for various conditions. Always inform your healthcare provider about all medications you are taking, including over-the-counter products like Orajel.
Are there other medications that might interact with Orajel?
While the interaction with sulfonamides is the primary concern, it’s always best to consult with a healthcare provider or pharmacist about potential interactions with any other medications you may be taking. This is especially important during pregnancy when medication use requires extra caution.
Proper Storage and Handling of Orajel
To ensure the safety and efficacy of Orajel, proper storage and handling are essential. Here are some key points to remember:
- Orajel has a shelf life of 3 years from the manufacturing date.
- No special storage conditions are required, but it’s best to keep it at room temperature and away from direct sunlight.
- Always check the expiration date before use.
- Keep out of reach of children.
- Do not use if the packaging appears tampered with or damaged.
Proper storage and handling not only ensure the product’s effectiveness but also help prevent accidental ingestion or misuse, which is particularly important in households with young children or during pregnancy.
When to Seek Professional Dental Care During Pregnancy
While Orajel can provide temporary relief from dental pain, it’s not a substitute for professional dental care, especially during pregnancy. Here are some situations when you should seek immediate dental attention:
- Persistent or severe tooth pain that doesn’t respond to over-the-counter remedies
- Swelling in the gums or face
- Fever accompanying dental pain
- Difficulty swallowing or breathing
- Any signs of infection, such as pus or foul taste
Remember, maintaining good oral health during pregnancy is crucial not only for the mother’s well-being but also for the developing fetus. Regular dental check-ups and prompt attention to dental issues are important aspects of prenatal care.
Is it safe to undergo dental procedures during pregnancy?
Many dental procedures are safe during pregnancy, especially during the second trimester. However, elective procedures are often postponed until after delivery. Always inform your dentist about your pregnancy, and they will work with your obstetrician to determine the safest course of action for your dental care.
In cases where dental treatment is necessary, your healthcare providers will weigh the benefits of treatment against any potential risks. Local anesthetics used in dentistry are generally considered safe during pregnancy when administered correctly.
Orajel Dental Gel – Summary of Product Characteristics (SmPC)
Last updated on emc: 30 Apr 2015
Print SmPC information
1. Name of the medicinal productOrajel®Dental Gel
2. Qualitative and quantitative compositionBenzocaine 10% w/w.
For full list of excipients, see Section 6.1.
3. Pharmaceutical formDental gel
4. Clinical particulars
4.1 Therapeutic indicationsFor temporary rapid relief of toothache pain associated with presence of open carious lesions and direct exposure of a vital dental pulp.
4.2 Posology and method of administration
Adults and children aged 12 years and over.
Directions:
• Remove cap
• Cut off tip of tube on score mark.
• With a clean finger or swab apply an amount of gel the size of a green pea into the tooth cavity.
• Use up to 4 times daily.
• Do not use continuously. If toothache persists, consult your dentist.
Not for use in children below the age of 12 years.
4.3 ContraindicationsKnown sensitivity to benzocaine or any of the other ingredients.
Not to be used in those individuals suspected of lacking the normal ability to convert methaemoglobin to haemoglobin, see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects.
Not for use in children below the age of 12 years.
4.4 Special warnings and precautions for useOrajel® is intended for short-term use until a dentist can be consulted. Do not use continuously. Do not exceed recommended dose.
The product contains sorbic acid which may cause local skin reactions, e.g. contact dermatitis.
Avoid drinking hot liquids whilst using Orajel®.
Do not use if there is a family history of methaemoglobinaemia.
4.5 Interaction with other medicinal products and other forms of interaction Benzocaine, like other derivatives of para-aminobenzoic acid, inhibits the actions of sulphonamides and therefore should not be used concomitantly with any sulphonamide.
4.6 Pregnancy and lactation There is inadequate evidence of safety of benzocaine in human pregnancy, but it has been in wide use for many years without apparent ill consequences. No clinical data are available on the use of this product during pregnancy and lactation.
4.7 Effects on ability to drive and use machines No effect on subjects’ ability to drive or operate machines.
4.8 Undesirable effects Application of benzocaine on skin and mucous membranes has resulted in hypersensitivity reactions (burning, stinging, pruritis, erythema, rash and oedema), contact dermatitis and methaemoglobinaemia in a few cases in infants, children and adults.
If symptoms persist, or are severe, or are accompanied by fever, headache, breathlessness, nausea and vomiting, consult a doctor.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose Excessive absorption of benzocaine may produce methaemoglobinaemia in infants, children, and adults. The first clinical signs are cyanotic (greyish) skin discolouration (most notably on mucous membranes) and signs of unusual breathing or breathlessness.
Methaemoglobinaemia may be treated by the intravenous administration of 1% methylene blue. Treatment of overdose should be symptomatic and supportive.
5. Pharmacological properties
5.1 Pharmacodynamic propertiesPharmacotherapeutic group: Local anaesthetics, ATC code: N01BA05
Benzocaine is a local anaesthetic of the ester type with rapid onset, acting to produce reversible loss of sensation by preventing or diminishing the generation and transmission of sensory nerve impulses near the site of application.
Depolarisation of the neuronal membrane and ion exchange are reversibly inhibited.
5.2 Pharmacokinetic propertiesBenzocaine is absorbed through mucous membranes and damaged skin.
Anaesthetics of the ester type are hydrolysed by esterases in the plasma and, to a lesser extent, in the liver.
5.3 Preclinical safety data There are no additional pre-clinical data of relevance to the prescriber.
6. Pharmaceutical particulars
6.1 List of excipients Macrogol 400
Polyethylene Glycol 3350S
Sodium Saccharin
Sorbic Acid
Natural Spearmint Flavour
Clove Oil
Citric acid
6.2 Incompatibilities Not applicable.
6.3 Shelf life 3 years
6.4 Special precautions for storage No special precautions for storage.
6.5 Nature and contents of container Low density polyethylene tube with external acrylate coating, medium density polypropylene cap.
Tubes contain 5.3 g gel.
6.6 Special precautions for disposal and other handlingNot applicable
7. Marketing authorisation holderChurch & Dwight UK Limited
Premier House, Shearway Business Park
Pent Road,
Folkestone, Kent,
CT19 4RJ
United Kingdom
8. Marketing authorisation number(s) PL 00203/0227
9. Date of first authorisation/renewal of the authorisation 21 September 2000
10. Date of revision of the text08 April 2015
IF APPLICABLE
IF APPLICABLE
Benzocaine topical Use During Pregnancy
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Medically reviewed by Drugs.com. Last updated on May 29, 2023.
Benzocaine topical is also known as: Anbesol, BeeGentle, Benz-O-Sthetic, Benzodent, Boil Ease Pain Relieving, Cepacol Dual Relief Sore Throat, Cepacol Fizzlers, Cepacol Sensations Hydra, Cepacol Sensations Warming, Cepacol Sore Throat & Coating, Cepacol Ultra, Chloraseptic Sore Throat Relief Strips, Dermoplast, Hurricaine, Kank-a, Laryngesic, Opahl, OraMagic Plus, Orabase, Orajel, Outgro Pain Relief, Sting Relief, Topical Anesthetic Dental Gel, Zilactin Tooth and Gum Instant Pain Reliever, Zilactin-B
Benzocaine topical Pregnancy Warnings
Benzocaine topical has been assigned to pregnancy category C by the FDA.
Animal studies have not been reported. There are no controlled data in human pregnancy. Benzocaine topical is only recommended for use during pregnancy when benefit outweighs risk.
See references
Benzocaine topical Breastfeeding Warnings
There are no data on the excretion of benzocaine topical into human milk.
See references
See also
- Benzocaine use while Breastfeeding (in more detail)
- benzocaine topical Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
References for pregnancy information
- Product Information. Solarcaine Plus Aloe (benzocaine topical). Schering-Plough Healthcare Products. 2005.
- Product Information. Americaine Hemorrhoidal (benzocaine topical). Novartis Consumer Health. 2005.
- Product Information. Dermoplast (benzocaine topical).
MedTech Inc. 2005. - Product Information. Outgro Pain Relief (benzocaine topical). MedTech Inc. 2005.
- Product Information. Cepacol Lozenges (cetylpyridinium topical). GlaxoSmithKline Inc. 2005.
- Product Information. Chloraseptic (benzocaine topical). Procter and Gamble Pharmaceuticals. 2005.
- Product Information. Vagisil Feminine Cream (benzocaine topical). Combe Inc. 2005.
- Product Information. Lanacane (benzocaine topical). Combe Inc. 2005.
- Product Information. Lanacane with Aloe (benzocaine topical). Combe Inc. 2005.
- Product Information. Hurricaine (benzocaine topical). Beutlich. 2005.
MedTech Inc. 2005.References for breastfeeding information
- Product Information. Solarcaine Plus Aloe (benzocaine topical). Schering-Plough Healthcare Products. 2005.
- Product Information. Americaine Hemorrhoidal (benzocaine topical). Novartis Consumer Health. 2005.
- Product Information. Dermoplast (benzocaine topical). MedTech Inc. 2005.
- Product Information. Outgro Pain Relief (benzocaine topical). MedTech Inc. 2005.
- Product Information. Cepacol Lozenges (cetylpyridinium topical). GlaxoSmithKline Inc. 2005.
- Product Information. Chloraseptic (benzocaine topical). Procter and Gamble Pharmaceuticals. 2005.
- Product Information. Vagisil Feminine Cream (benzocaine topical). Combe Inc. 2005.
- Product Information. Lanacane (benzocaine topical). Combe Inc. 2005.
- Product Information. Lanacane with Aloe (benzocaine topical). Combe Inc. 2005.
- Product Information. Hurricaine (benzocaine topical). Beutlich. 2005.
2005.Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
📜 Instructions for use Relief ® Advance 💊 Composition of Relief ® Advance ✅ Use of Relief ® Advance 📅 Storage conditions Relief ® Advance ⏳ Shelf life Relief ® 9 0007 Advance Keep for yourself Search for analogues Interaction Product Description Relief ® Advance Based on the official instructions for use of the drug, approved by the manufacturer Marketing authorization holder: BAYER JSC Produced:ISTITUTO de ANGELI, S.r.L. (Italy) (Russia) Contacts for inquiries: BAYER AG ATX code: D04AB04 (benzocaine) Active substance: Rec.INN WHO registered Dosage form
Release form, packaging and composition |
06.30
rectal 206 mg: 12 pcs.
| K60 | Fissure and fistula of the anus and rectum |
| K64 | Hemorrhoids and perianal venous thrombosis |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
Z98. 8 | Other specified post-surgical conditions |
Dosing regimen
Rectal. The drug should be used after hygiene procedures.
Adults and children over 12 years of age: inject 1 suppository into the rectum up to 4 times / day (morning, at night and after each bowel movement) for 7 days. If necessary, on the recommendation of a doctor, the course of treatment can be extended up to 3 weeks.
Children under 12 years of age: the drug should be used only on prescription.
If there is no improvement after treatment or the symptoms worsen or new symptoms appear, the patient should consult a doctor.
The drug should be used according to the indications, the method of application and in the doses indicated in the instructions.
Adverse effects
The following adverse reactions have been reported with the use of preparations containing benzocaine under various conditions./464678455-56a7702b3df78cf77295f475.jpg)
Since these reactions are listed in the reference materials, or voluntarily come from the population in an indefinite number, it is not always possible to reliably estimate their frequency or establish a causal relationship with the use of the drug.
From the immune system: allergic reactions.
From the blood and lymphatic system: methemoglobinemia.
Skin and subcutaneous tissue disorders: allergic dermatitis.
General and local reactions: erythema, local irritation, swelling, pain, rash at the application site.
If the patient notices other side effects, the physician should be informed.
Contraindications for use
- hypersensitivity to drug components;
- thromboembolic disease;
- granulocytopenia.
Use during pregnancy and lactation
Relief ® Advance is used during pregnancy and lactation (breastfeeding) only after consulting a doctor.
Use in children
It is not recommended to use the drug in children under 12 years of age without medical advice.
Special instructions
In case of accidental ingestion, seek qualified help immediately.
In case of heavy bloody discharge from the anus or if symptoms persist for more than 7 days, consult a physician.
It is not recommended to use the drug on damaged skin, because. this may increase systemic absorption.
There are reports that products containing benzocaine can cause methemoglobinemia. Symptoms such as cyanosis of the skin, lips and nails, headache, dizziness, shortness of breath (difficulty in breathing), weakness, tachycardia that are observed during treatment may indicate a potentially life-threatening methemoglobinemia that requires immediate medical attention.
To minimize systemic side effects, do not exceed the recommended daily dose unless directed otherwise by a physician.
Pediatric use
Not recommended for use in children under 12 years of age without medical advice.
Influence on the ability to drive vehicles and mechanisms
No effect.
Overdose
Symptoms of may be related to the pharmacological effects of benzocaine. Its systemic absorption in case of overdose can be manifested by drowsiness, anxiety, agitation; in severe cases – convulsions. Very rarely, benzocaine in high doses can cause methemoglobinemia, which is manifested by respiratory disorders and cyanosis.
Treatment: for methemoglobinemia – intravenous administration of methylene blue.
Drug interactions
Drug interactions with Relief ® Advance are not described.
Storage conditions for Relief
® Advance
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Shelf life of Relief
® Advance
Shelf life – 2 years. Do not use after the expiration date.
Terms of sale
The drug is sold without a prescription.
CH-20230630-98
Contacts for inquiries
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If you want to place a link to the description of this drug – use this code
Relief ® Advance . Description of the drug in the reference book Vidal.
Orajel Non Medicated Cooling Swabs Teething reviews and…
078Z”> Published September 23, 2022
Great for teething!
Drew P. Panah
Level 1
1317 Review
38 Karma
My baby is restless because of teething. 10/01/2019 she will be 4 months old. I rubbed her gums with this substance, and after sucking on a cotton swab, she immediately fell asleep. I don’t worry for more than an hour, although it has been non-stop for the last two days.
Pros
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Nothing
MY AWESOME BABY IS APPROVED!
Bill G. Garczynski
Netherlands, Amsterdam
Level 1
656 Review
65 Karma
I love this product! Whenever I use this on my 3 month old LO, he smiles every time, pointing out his resemblance to him.
The only reason I took off a star is for instant relief :/ I will definitely still keep it in my first aid kit even though it’s a must!
Pros
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Modern
Ehh idk didn’t work for me
Aaron U. Urena
1 level
1277 Review
55 Karma
I really wanted to like them, but I feel like there just aren’t very many and they don’t work either, at least in my experience. I would advise to just take a Q-tip and put the gel on a Q-tip rather than buying them, there aren’t many of them and I don’t see much of a difference.
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559Z”> Updated on September 23, 2022
Miracle Worker!: Child Care
Michael V Vargas
Level 1
1233 Review
22 Karma
Amazing for picky and picky kids! My four month old baby cried all day and didn’t sleep and nothing else helped. One hit with that stick and he finally dozed off! I am glad to know that he can sleep peacefully and at the same time I can give him something for the pain. I do not regret my purchase and will buy more!
Pros
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Slightly wrinkled
BUY NOW. DO NOT ASK QUESTIONS. BELIEVE ME
Roberto N. Nastanovich
Iran, Tehran
Level 1
606 Review
37 Karma
My child was moody all day long, that is all day long.
never slept However, he usually sleeps every two hours. Today he didn’t, he’s 4 months old and I thought his teeth should be ready to cut through my baby’s soft gums. I put this substance on his gums. Fell asleep within 2 minutes. Since then I have been sleeping. It’s been two hours. Necessary!
Pros
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Slightly torn
The child loves them, that’s the main thing
Maurice M. Matlock
Spain, Madrid
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689 Review
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I gave these 5 stars because my baby loves them and they help soothe them when I feel sore gums during teething. I took off a star for the packaging because I couldn’t find a way to open it easily and more often than not, all the cotton buds inside break when I finally open them.