Label: ANTISEPTIC- cetylpyridinium chloride rinse
- NDC Code(s): 36800-299-21, 36800-299-86
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
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 August 5, 2022
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- Active ingredient
- USE
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Warnings
for this product only
- Directions
- other information
- Inactive ingredients
- Questions?
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SPL UNCLASSIFIED SECTION
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
TopCare everyday
- Kills germs for better oral hygiene
- Helps reduce plaque bacteria
- Helps prevent gingivitis
- Freshens breath
This rinse may cause temporary staining 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 Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint
DISTRIBUTED BY TOPCO ASSOCIATES, LLC
ELK GROOVE VILLAGE, IL 60077
QUESTIONS? 1-888-423-0139
topcare@topcare.com www.topcarebrand.com
This Top Care product is laboratory tested to guarantee its hightest quality. Your total satisfaction is guaranteed.
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-299 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLOXAMER 188 (UNII: LQA7B6G8JG) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) BENZOIC ACID (UNII: 8SKN0B0MIM) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-299-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/1993 2 NDC:36800-299-21 89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/1993 3 NDC:36800-299-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/03/1993 Labeler - Topco Associates LLC (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(36800-299) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(36800-299)