Label: ANTISEPTIC ORAL CLEANSER- hydrogern peroxide mouthwash
- NDC Code(s): 55910-171-34
- Packager: OLD EAST MAIN CO.
- 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 September 23, 2022
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- Official Label (Printer Friendly)
- Active ingredient
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Use
▪ aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
▪ for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums
▪ for temporary use to cleanse canker sores
▪ assists in the removal of foreign material from minor oral wounds - WARNINGS
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Directions
adults and children 2 years of age and older: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out
▪ use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
▪ children under 12 should be supervised in the use of the product
▪ children under 2 years of age: consult a dentist or doctor - Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
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INGREDIENTS AND APPEARANCE
ANTISEPTIC ORAL CLEANSER
hydrogern peroxide mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-171 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 150 mg in 100 L Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MENTHOL (UNII: L7T10EIP3A) METHYL SALICYLATE (UNII: LAV5U5022Y) POLOXAMER 338 (UNII: F75JV2T505) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-171-34 .236 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/19/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 04/19/2009 Labeler - OLD EAST MAIN CO. (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-171) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-171)
