Label: ANTICAVITY RINSE- sodium fluoride mouthwash
- NDC Code(s): 49035-004-44
- Packager: Wal Mart
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 16, 2023
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- Official Label (Printer Friendly)
- OTHER SAFETY INFORMATION
- Active ingredient
- Purpose
- Use
- warnings
- Keep out of reach of children.
-
Directions
- adults and children 6 year of age and older: use once a day after brushing your teeth with a toothpaste
- remove cap
- pour 10 milliliters (10 mL mark on inside of cap), do not fill above 10 mL mark
- vigorously swish 10 milliliters 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 year of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- ADVERSE REACTIONS SECTION
-
principal display panel
NDC: 49035-004-44
equate
Compare to ACT Active Ingredient*
Kids Anticavity Fluoride Rinse
- Strong cavity protection
- Helps strengthen teeth
- Alcohol free
Bubble Gum Flavor
ADA Accepted
American Dental Assoication
- Helps prevent cavities
IMPORTANT: Read directions for proper use
18 FL OZ (532 mL)
Made in the USA with 90% or more US parts
Factory Certified
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INGREDIENTS AND APPEARANCE
ANTICAVITY RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) D&C RED NO. 33 (UNII: 9DBA0SBB0L) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE (UNII: SE337SVY37) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-004-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/06/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/06/2004 Labeler - Wal Mart (051957769) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(49035-004) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(49035-004)