FIXODENT GUM CARE- cetylpyridinium chloride rinse

Fixodent by

Drug Labeling and Warnings

Fixodent by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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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)

INGREDIENTS AND APPEARANCE

FIXODENT  GUM CARE
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-169
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.07 g  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-169-36	36 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2018
2	NDC: 37000-169-25	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2018
3	NDC: 37000-169-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2018
4	NDC: 37000-169-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2018
5	NDC: 37000-169-15	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2018

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)