Label: ANTISEPTIC- cetylpyridinium chloride rinse
- NDC Code(s): 49035-299-12, 49035-299-86
- Packager: Wal-Mart Stores, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 23, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- use
- Warnings
- Stop use and ask a dentist if
- Keep out of reach of children under 6 years of age
- Directions
- Other information
- Inactive ingredients
- Questions
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SPL UNCLASSIFIED SECTION
Alcohol Free Multi-Action Antiseptic Oral Rinse
Sealed with printed Neckband for your protection
This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.
Statisfaction guaranteed. For questions or comments please call 1-888-287-1915.
Distributed by Wal-Mart Stores. INC
Bentonville AR72716
*This product is not manufactured or distributed by Procter & Gamble distributor of Crest Pro-Health Rinse Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint
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Equate
Compare to Crest Pro-Health Rinse Multi-Protection Active Ingredient
Alcohol Free Multi-Action Oral Rinse
Antigingivitis/Antiplaque
2X/Day Protection
- Kills germs
- Helps prevent plaque
- Helps prevent gingivitis
- Helps keep teeth feeling clean
- Freshens breath
- No burn of alcohol
Zesty Mint
Use morning & night for better oral hygiene
1 L (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-299 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:49035-299-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/22/2008 2 NDC:49035-299-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/22/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/22/2008 Labeler - Wal-Mart Stores, Inc (051957769) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(49035-299) Establishment Name Address ID/FEI Business Operations Vi-Jon 088520668 manufacture(49035-299)