Drugplain

Orajel Antiseptic Rinse For All Mouth Sores 15 mg/mL

Hydrogen Peroxide and Menthol · LIQUID · Church & Dwight Co., Inc.

No Recall History
Plain English

Orajel Antiseptic Rinse For All Mouth Sores is a liquid containing hydrogen peroxide and menthol at 15 mg/mL, taken oral. Manufactured by Church & Dwight Co., Inc..

Key Facts

Brand Name
Orajel Antiseptic Rinse For All Mouth Sores
Generic Name
Hydrogen Peroxide and Menthol
NDC Code (Product)
10237-760
Manufacturer
Church & Dwight Co., Inc.
Strength
15 mg/mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M022
Marketing Start
11/01/2014

Recall History

No Recall History

Side Effects Reported to FDA

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

facial paralysis1 reports
hypoaesthesia1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

first aid to help reduce bacteria in minor oral wounds for temporary pain relief and use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures accidental injury orthodontic appliances canker sores dentures other irritations of the mouth and gums Aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth

Dosage & Administration

Directions remove imprinted safety seal from bottle cap to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed. Adults and children 2 years of age and older Swish one-half capful (2 tesapoons=10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider Children under 12 years of age Should be supervised in the use of this product Children under 2 years of age Consult a dentist or healthcare provider

Warnings

When using this product do not swallow do not exceed recommended dosage Do not use this product for more than 7 days unless directed by a dentist or healthcare provider Stop use and see your physician promptly if swallowing, rash or fever develops; irritation, pain or redness persists or worsens; sore mouth symptoms do not improve in 7 days Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Frequently Asked Questions

What is Orajel Antiseptic Rinse For All Mouth Sores used for?

Orajel Antiseptic Rinse For All Mouth Sores contains Hydrogen Peroxide and Menthol. It is a liquid taken oral. Consult your doctor for specific uses.

Is Orajel Antiseptic Rinse For All Mouth Sores a controlled substance?

Orajel Antiseptic Rinse For All Mouth Sores is not classified as a controlled substance by the DEA.

What is the generic name for Orajel Antiseptic Rinse For All Mouth Sores?

The generic name for Orajel Antiseptic Rinse For All Mouth Sores is Hydrogen Peroxide and Menthol. There are no other listed brand versions of Hydrogen Peroxide and Menthol.

What is the NDC code for Orajel Antiseptic Rinse For All Mouth Sores 15 mg/mL?

The NDC (National Drug Code) for Orajel Antiseptic Rinse For All Mouth Sores 15 mg/mL is 10237-760, listed by Church & Dwight Co., Inc..

Product NDC

10237-760

Package NDC

10237-760-16

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

Data from openFDA · Public domain (CC0 1.0)