Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 37012-004-44
- Packager: Shopko Stores Operating Co.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 January 11, 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 once a day after brushing your teeth with toothpaste
- remove cap
- pour 10 mililiters (10 mL mark on inside of cap); do not fill above thr 10 mL mark
- vigorously swish 10 mililiters 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
-
SPL UNCLASSIFIED SECTION
Sealed with printed neckband for your protection.
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Bubblegum Anticavity Kids Fluoride Rinse.
Manufactured by Vi-Jon, LLC.,
One Swan Dr., Smyrna, TN 37167
for ShopKo Stores Operating Co., LLC
www.shopko.com
For consumer questions call 1-888-593-05936
ShopKo Satisfaction Guaranteed By Refund Or Exchange
- principal display panel
-
INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-004 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:37012-004-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/15/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/15/2011 Labeler - Shopko Stores Operating Co.LLC (023252638) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(37012-004) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(37012-004)
