Label: SORE MOUTH CLEANSER- hydrogen peroxide mouthwash
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- NDC Code(s): 0869-0462-34
- Packager: Vi-Jon, LLC
- 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 May 17, 2022
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- TEP
- active ingredient
- Purpose
-
Uses
- aids in the removal of phlgem, 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, acidental injury, or other irritations of the mouth and gums
- for temporary use to clanse canker sores
- assists in the removal of foreign material from minor oral wounds
- Warnings
- Do not use
- When using this product
- Keep out of reach of children
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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 pysicial
- 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
- Disclaimer
- Adverse Reactions
- Principal display panel
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INGREDIENTS AND APPEARANCE
SORE MOUTH CLEANSER
hydrogen peroxide mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0462 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 1588 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLOXAMER 338 (UNII: F75JV2T505) POLYSORBATE 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0869-0462-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/02/2017 Labeler - Vi-Jon, LLC (790752542) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(0869-0462) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(0869-0462)
