Label: ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid
- NDC Code(s): 37012-482-86
- Packager: ShopKo Stores Operating., LLC
- 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 March 3, 2022
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 daily after brushing your teeth with a toothpaste
- vigorously swish 10 mL (2 teaspoonfuls) of rinse between 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 without supervision
- children under 6 years of age: consult a dentist or doctor
- Inactive ingredients
-
SPL UNCLASSIFIED SECTION
Sealed with printed neckband for your protection
To Open:
1. Remove Printed Tamper Evident Neckband
2. Squeeze Both tabs at Base of cap While turning the cap until loose.
To Close: Place cap back on bottle and turn cap until it clicks twice and feels secure.This rinse may cause temporary staing to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.
*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse
Manufactured by Vi-Jon, Inc
One Swan Dr., Smyrna, TN 37167
for ShopKo Stores Operating Co., LLC
www.shopko.com
for consumer questions
call 1-888-593-0593
- principal display panel
-
INGREDIENTS AND APPEARANCE
ALCOHOL-FREE ANTICAVITY
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-482 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) 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) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-482-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1982 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/15/1982 Labeler - ShopKo Stores Operating., LLC (023252638) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(37012-482) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(37012-482)
