Drugplain

Orajel 3X Medicated For All Mouth Sores 200 mg/g

Benzocaine, Menthol, Zinc Chloride · GEL · Church & Dwight Co., Inc.

No Recall History
Plain English

Orajel 3X Medicated For All Mouth Sores is a gel containing benzocaine, menthol, zinc chloride at 200 mg/g, taken topical. Manufactured by Church & Dwight Co., Inc..

Key Facts

Brand Name
Orajel 3X Medicated For All Mouth Sores
Generic Name
Benzocaine, Menthol, Zinc Chloride
NDC Code (Product)
10237-783
Manufacturer
Church & Dwight Co., Inc.
Strength
200 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
11/01/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

anaemia macrocytic1 reports
dyspnoea1 reports
methaemoglobinaemia1 reports
oxygen saturation decreased1 reports
palpitations1 reports
pharyngeal hypoaesthesia1 reports
troponin increased1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

Dosage & Administration

Directions Adults and children 2 years of age and over Apply to affected area up to 4 times daily or as directed by a dentist or doctor Children between 2 and 12 years of age Ask a doctor before use. Should be supervised in the use of this product Children under 2 years of age Do not use

Warnings

Methemoglobinemia warning : use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy Allergy alert : do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Frequently Asked Questions

What is Orajel 3X Medicated For All Mouth Sores used for?

Orajel 3X Medicated For All Mouth Sores contains Benzocaine, Menthol, Zinc Chloride. It is a gel taken topical. Consult your doctor for specific uses.

Is Orajel 3X Medicated For All Mouth Sores a controlled substance?

Orajel 3X Medicated For All Mouth Sores is not classified as a controlled substance by the DEA.

What is the generic name for Orajel 3X Medicated For All Mouth Sores?

The generic name for Orajel 3X Medicated For All Mouth Sores is Benzocaine, Menthol, Zinc Chloride. There are 4 other brand versions of Benzocaine, Menthol, Zinc Chloride.

What is the NDC code for Orajel 3X Medicated For All Mouth Sores 200 mg/g?

The NDC (National Drug Code) for Orajel 3X Medicated For All Mouth Sores 200 mg/g is 10237-783, listed by Church & Dwight Co., Inc..

Product NDC

10237-783

Package NDC

10237-783-12

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)