Label: ANTISEPTIC- cetylpyridinium chloride mouthwash
- NDC Code(s): 37012-299-86
- Packager: Shopko Stores Operating
- 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 July 1, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Stop use and ask a dentist if
- Keep out of reach of children under 6 years of age
- Other information
- Inactive ingredients
SPL UNCLASSIFIED SECTION
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.
Sealed with printed neckband for your protection
*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Rinse
Manufactured by Vi-Jon, Inc.,
One Swan Drive., Smyrna, TN37167
For Shopko Stores Operating Co., LLC
For consumer questions call 1-888-593-0593
Shopko Satisfaction Guaranteed By Refund Or Exchange
- principal display panel
INGREDIENTS AND APPEARANCE
cetylpyridinium chloride mouthwash
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-299 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) Other Ingredients Ingredient Kind Ingredient Name Quantity Does not contain FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-299-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/13/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/13/2009 Labeler - Shopko Stores Operating (023252638) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(37012-299) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(37012-299)