Label: ANTISEPTIC- cetylpyridinium chloride rinse
- NDC Code(s): 50804-299-86
- Packager: Perrigo Direct, 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.
Updated October 3, 2022
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- Active ingredient
for this product
Stop use and ask a dentist if
- gingivitis, bleeding or redness persists for more than 2 weeks
- you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
- DOSAGE & ADMINISTRATION
- Other information
- Inactive ingredients
SPL UNCLASSIFIED SECTION
This rinse may cause temporary staining to the surface of teeth.
This is not harmful, and adequate brushing may prevent its occurrence.
This product is not manufactured or distributed by Procter & Gamble, distributor of
Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint
**Killed at least 99% of representative plaque organisms commonly
associated with gingivitis in as little as 15 seconds
Distributed by: Perrigo Direct, Inc.
Peachtree City, GA 30269
GoodSense is a registered trademark of L. Perrigo Company.
principal display panel
Alcohol Free Antiseptic Oral Rinse
Kills 99% of Germs for a healthier Mouth**
Helps prevent Plaque
Helps prevent gingivitis
Helps keep teeth feeling clean
No burn of alcohol
Compare to active ingredients of Crest Pro-Health Rinse*
1 LITER (33.8 FL OZ)
INGREDIENTS AND APPEARANCE
cetylpyridinium chloride rinse
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-299 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:50804-299-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/20/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/20/1993 Labeler - Perrigo Direct, Inc (076059836) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(50804-299) Establishment Name Address ID/FEI Business Operations Vi-Jon 088520668 manufacture(50804-299)