CREST ANTICAVITY FLUORIDE- sodium fluoride 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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Crest ®

Anticavity Fluoride Rinse

Drug Facts

Active ingredient

Sodium Fluoride 0.022% (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

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

HELPS YOU GET
BETTER DENTAL
CHECK-UPS

Crest ®
ANTICAVITY FLUORIDE RINSE

SENSI • CARE™
WITH FLUORIDE - ALCOHOL FREE
FORMULA

  • STRENGTHENS ENAMEL
    WEAKENED BY ACIDS
    **
  • HELPS PREVENT CAVITIES
  • CLEANS TEETH & GUMS
  • FRESHENS BREATH
  • NO BURN OF ALCOHOL

MILD MINT

IMPORTANT: Read directions for proper use.

DOES NOT RELIEVE OR TREAT SENSITIVE
TEETH, ORAL PAIN OR GUM DISEASE

500 mL (16.9 FL OZ)

96677460

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
CREST  ANTICAVITY FLUORIDE
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-854
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
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
ColorturquoiseScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-854-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/201412/01/2018
2NDC:37000-854-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/201412/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/17/201412/01/2018
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2016
 
The Procter & Gamble Manufacturing Company