Drugplain

Orajel Medicated for Toothache and Gum, Liquid 200 mg/mL

Benzocaine and Menthol · LIQUID · Church & Dwight Co., Inc.

No Recall History
Plain English

Orajel Medicated For Toothache And Gum is a topical liquid containing benzocaine and menthol that temporarily relieves tooth and gum pain when applied directly to the affected area. This over-the-counter product works by numbing the area and providing a cooling sensation to help soothe dental discomfort.

Key Facts

Brand Name
Orajel Medicated for Toothache and Gum, Liquid
Generic Name
Benzocaine and Menthol
NDC Code (Product)
10237-796
Manufacturer
Church & Dwight Co., Inc.
Strength
200 mg/mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
08/07/2020

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use for the temporary relief of pain due to • canker sores • minor injury of the mouth and gums • minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Dosage & Administration

Directions • remove imprinted safety seal from bottle cap Adults and children 2 years of age and over Apply product with cotton swab or finger to the affected area. Use up to 4 times daily or as directed by a dentist or doctor Children under 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 cuse methemoglobinemia, a serious condition that must be treated promptly becasue it reduces the amount of oxygen carried in the 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 or 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 Flammable : keep away from fire or flame. Avoid smoking during application.

Frequently Asked Questions

What is Orajel Medicated for Toothache and Gum, Liquid used for?

Orajel Medicated For Toothache And Gum is a topical liquid containing benzocaine and menthol that temporarily relieves tooth and gum pain when applied directly to the affected area. This over-the-counter product works by numbing the area and providing a cooling sensation to help soothe dental discomfort.

Is Orajel Medicated for Toothache and Gum, Liquid a controlled substance?

Orajel Medicated for Toothache and Gum, Liquid is not classified as a controlled substance by the DEA.

What is the generic name for Orajel Medicated for Toothache and Gum, Liquid?

The generic name for Orajel Medicated for Toothache and Gum, Liquid is Benzocaine and Menthol. There are 11 other brand versions of Benzocaine and Menthol.

What is the NDC code for Orajel Medicated for Toothache and Gum, Liquid 200 mg/mL?

The NDC (National Drug Code) for Orajel Medicated for Toothache and Gum, Liquid 200 mg/mL is 10237-796, listed by Church & Dwight Co., Inc..