FIXODENT GUM CARE- cetylpyridinium chloride rinse 
The Procter & Gamble Manufacturing Company

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.

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Fixodent® Gum Care

Drug Facts

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis/antiplaque

Uses

  • helps prevent and reduce plaque and gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Warnings

Ask a dentist if symptoms persist or condition worsens after regular use.

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use
  • adults and children 6 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
    • do not swallow
    • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use

Inactive ingredients

water, glycerin, flavor, poloxamer 407, sodium saccharin, methylparaben, sucralose, propylparaben, blue 1

Questions?

1–800–214-8871

DISTR. BT PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 250 ML Bottle Label

ALCOHOL FREE

FRESHENS BREATH

from the makers of

#1

Denture Adhesive Brand

Fixodent®
CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

GUM CARE

CLEANS & PROTECTS GUMS

For Partials and Denture Wearers woth Some Natural Teeth

250 mL (8.4FL OZ)

169

FIXODENT  GUM CARE
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-169
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 g  in 20 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-169-3636 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/201810/31/2022
2NDC:37000-169-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/201810/31/2022
3NDC:37000-169-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/201810/31/2022
4NDC:37000-169-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/201810/31/2022
5NDC:37000-169-151500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/201810/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/28/201810/31/2022
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 4/2023
Document Id: f8fe293c-46cd-1372-e053-6294a90a67d8
Set id: 7bbbd54d-0218-3f61-e053-2a91aa0a0228
Version: 4
Effective Time: 20230410
 
The Procter & Gamble Manufacturing Company