Fixodent Gum Care: Package Insert and Label Information

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.

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
(click image for full-size original)
FIXODENT GUM CARE
cetylpyridinium chloride rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-169
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 0.07 g in 20 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
POLOXAMER 407
METHYLPARABEN
SACCHARIN SODIUM
PROPYLPARABEN
FD&C BLUE NO. 1
SUCRALOSE
Product Characteristics
Color blue Score
Shape Size
Flavor WINTERGREEN Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-169-36 36 mL in 1 BOTTLE, PLASTIC None
2 NDC:37000-169-25 250 mL in 1 BOTTLE, PLASTIC None
3 NDC:37000-169-50 500 mL in 1 BOTTLE, PLASTIC None
4 NDC:37000-169-01 1000 mL in 1 BOTTLE, PLASTIC None
5 NDC:37000-169-15 1500 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 11/28/2018
Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 01/2020 The Procter & Gamble Manufacturing Company

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