Label: SORE MOUTH CLEANSER- hydrogen peroxide mouthwash
- NDC Code(s): 41250-750-34, 41250-750-77
- Packager: Meijer
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 3, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 cleanse 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 pysician
- 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
- Questions?
- Disclaimer
- Tamper Evident Statement
- Adverse Reactions
- Principal display panel
-
INGREDIENTS AND APPEARANCE
SORE MOUTH CLEANSER
hydrogen peroxide mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-750 Route of Administration TOPICAL 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 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:41250-750-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2017 2 NDC:41250-750-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 12/01/2017 Labeler - Meijer (006959555) Registrant - Vi-Jon, LLC (088520668) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41250-750) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41250-750)
