Drug Facts

Active ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

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

Directions

Adults and children 6 years & older:
Use twice a day after brushing your teeth with a toothpaste.
Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
Do not swallow the rinse.
Do not eat or drink for 30 minutes after rinsing.
Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
Children under 6 years of age: Consult a dentist or doctor.

Inactive ingredients

water, glycerin, flavor, poloxamer 407, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, sucralose, propylparaben, disodium phosphate, yellow 6, green 3

Questions?

1–800–285–9139

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

+ FLUORIDE

Crest

PRO-HEALTH

ADVANCED

ANTICAVITY FLUORIDE MOUTHWASH

ALCOHOL FREE

ANTI-CAVITY

IMPORTANT:

Read directions for proper use

MAX CAVITY

PROTECTION

PROTECTS AGAINST CAVITIES

REBUILDS WEAKENED ENAMEL

STRENGTHENS TEETH

CLEANS THE WHOLE MOUTH

FRESHENS BREATH

NO ALCOHOL BURN

500 mL

(16.9 fl oz)

Label

CREST PRO-HEALTH ADVANCED ANTI-CAVITY MAX CAVITY
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69423-848
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.2 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
METHYLPARABEN (UNII: A2I8C7HI9T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69423-848-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2020
2	NDC:69423-848-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2020
3	NDC:69423-848-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	01/31/2020

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Crest ® Pro-Health Advanced Anti-Cavity Max Cavity Protection