Label: ORAL SORE ANTISEPTIC- hydrogen peroxide, menthol liquid
- NDC Code(s): 37808-024-43
- Packager: H E B
- 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 17, 2023
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- active ingredients
- purpose
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uses
▪ first aid to help protect against bacterial contamination in minor oral wounds
▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures ▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores
▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouthUses
▪ first aid to help protect against bacterial contamination in minor oral wounds
▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures
▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores
▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouth - warnings
- When using this product
- Keep out of reach of children
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directions
Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician
Children under 12 years of age - should be supervised in the use of the product
Children under 2 years of age - consult a dentist or doctor
- other information
- inactive ingredients
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INGREDIENTS AND APPEARANCE
ORAL SORE ANTISEPTIC
hydrogen peroxide, menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) METHYL SALICYLATE (UNII: LAV5U5022Y) PHOSPHORIC ACID (UNII: E4GA8884NN) POLOXAMER 338 (UNII: F75JV2T505) POLYSORBATE 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) water (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-024-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/15/2020 Labeler - H E B (007924756) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations VI-Jon, LLC 790752542 manufacture(37808-024) Establishment Name Address ID/FEI Business Operations VI-Jon, LLC 088520668 manufacture(37808-024)
