Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
- NDC Code(s): 36800-213-44
- Packager: Topco Associates, 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 May 24, 2023
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- Official Label (Printer Friendly)
- OTHER SAFETY INFORMATION
- Active ingredient
- Purpose
- Use
- Warning
- Keep out of reach of children.
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Directions
- adults and children 6 years 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 now 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 necessay until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- Questions?
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Adverse reactions
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash
DISTRIBUTED BY: TOCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
(C) TOPCO VIJ717 QUESTIONS? 1-888-423-0139
topcare@topcare.com www.topcarebrand.com
QUALITY GUARANTEED
This Top Care product is laboratory tested to guarantee its highest quality.
Your total satisfaction is guaranteed.
- Principal display panel
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INGREDIENTS AND APPEARANCE
ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-213 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 water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) MENTHOL (UNII: L7T10EIP3A) METHYL SALICYLATE (UNII: LAV5U5022Y) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) poloxamer 407 (UNII: TUF2IVW3M2) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE (UNII: SE337SVY37) SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BENZYL ALCOHOL (UNII: LKG8494WBH) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-213-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/20/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/20/2003 Labeler - Topco Associates, LLC (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(36800-213) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(36800-213)
