Label: ORAJEL ANTISEPTIC ALCOHOL-FREE MOUTH SORE RINSE- hydrogen peroxide, menthol liquid
- NDC Code(s): 10237-784-16
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 10, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
-
Uses
- 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
- orthodontic appliances
- dentures
- accidental injury
- canker sores
- other irritations of the mouth and gums
Aids in the removal of:
- phlegm
- mucus
- other secretions associated with occasional sore mouth
- Warnings
- Stop Use
- Keep out of reach of children
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Directions
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
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
#1 ORAL PAIN RELIEVER BRAND FOR ADULTS
With PAIN RELIEF!
Orajel
ALCOHOL FREE
FOR ALL MOUTH SORES
ANTISEPTIC RINSE
Canker Sores Cheek Bites Gum Irritation Irritation from Dentures or Braces
Promotes Healing
Kills Bacteria
Provides Pain Relief
SOOTHING MINT RINSE
16 FL OZ (473.2 mL)
ORAL DEBRIDING AGENT/ANTISEPTIC RINSE/PAIN RELIEVER
-
INGREDIENTS AND APPEARANCE
ORAJEL ANTISEPTIC ALCOHOL-FREE MOUTH SORE RINSE
hydrogen peroxide, menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-784 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 mg in 1 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) METHYL SALICYLATE (UNII: LAV5U5022Y) PHOSPHORIC ACID (UNII: E4GA8884NN) POLOXAMER 338 (UNII: F75JV2T505) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-784-16 473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 11/01/2019 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Canada Corp. 253933600 MANUFACTURE(10237-784)