Label: ORAL ANTIVAVITY- sodium fluoride mouthwash
- NDC Code(s): 76162-576-86
- Packager: Topco
- 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 7, 2022
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- Official Label (Printer Friendly)
- claims
- active ingredient
- Purpose
- Use
- WARNINGS
- Keep out of reach of children
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Directions
Adults and children 6 years of age and older:
- use twice daily after brushing your teeth with a toothpaste
- vigorously swish 10 mL (2 teaspoonfuls) of rinse bwtween your teeth for 1 minute then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using witout supervision
- children under 6 years of age: consult a dentist or doctor
- Inactive ingredients
- Questions?
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SPL UNCLASSIFIED SECTION
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLATE, IL 60007
©TOPCO VIJA0122 QUESTIONS? 1-888-423-0139
This rinse may cause temporary staining to the surface of teeth. This is not harmful, add adequate brushing may prevent its occurence
This product is not manufactured or distributed by Procter & Gamble, distributof of Crest Pro-Health Advanced Anticavity Fluoride Mouthwash
This product is not intended to replace brushing or flossing
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Principal display panel
COMPARE TO CREST PRO-HEALTH ADVANCED ANTICAVITY FLUORIDE MOUTHWASH
TopCare
everyday
ALOHOL FREE
Fluoride
Anticavity Mouthwash
REFRESHING MINT
- Helps strengthen enamel
- Helps prevent cavities
- Cleans teeth**
- Kills bad breath germs
- Freshens breath
- Helps keep mouth feeling clean
IMPORTANT: Read directions for proper use.
33.8 FL OZ (1 QT 1.8 FL OZ) 1 L
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INGREDIENTS AND APPEARANCE
ORAL ANTIVAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-576 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:76162-576-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/04/2022 Labeler - Topco (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(76162-576) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(76162-576)