Label: ANTICAVITY- sodium fluoride mouthwash
- NDC Code(s): 41163-011-45
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Keep out of reach of children.
-
Directions
Adults and children 6 years of age and older:
- use twice a day after brushing your teeth with a 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 after rinsing
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- TEP
- Disclaimer
- Other information
- Adverse reactions section
-
Principal display panel
compare to Listerine® HealthyWhite® Vibrant Anticavity Fluoride Mouthrinse active ingredient*
EQUALINE®
glowing white
anticavity
mouthrinse
- begins working on contact
- 5 days to whiter teeth
- helps strengthen teeth
- kills germs that cause bad breath
IMPORTANT: read directions for proper use.
fresh mint
32 FL OZ (1 QT) 946 mL
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-011 Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDROGEN PEROXIDE (UNII: BBX060AN9V) POLOXAMER 407 (UNII: TUF2IVW3M2) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) MENTHOL (UNII: L7T10EIP3A) PHOSPHORIC ACID (UNII: E4GA8884NN) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-011-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/18/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 12/18/2015 Labeler - United Natural Foods, Inc. dba UNFI (943556183) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41163-011) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41163-011)