Label: ALCOHOL FREE REFRESHING MINT- sodium fluoride mouthwash
- NDC Code(s): 37808-576-86
- Packager: HEB
- Category: HUMAN OTC DRUG LABEL
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 April 20, 2022
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- Keep out of reach of children
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Directions
Adults and children 6 years of age and oler:
- use twice a day after brushing your teeth with toothpaste.
- vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessare until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
ALCOHOL FREE REFRESHING MINT
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-576 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 10.41 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHOSPHORIC ACID (UNII: E4GA8884NN) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-576-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/27/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/27/2015 Labeler - HEB (007924756) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(37808-576) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(37808-576)