CREST PRO-HEALTH COMPLETE (FRESH MINT)- 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

PRO-HEALTH™

COMPLETE

FRESH MINT

Drug Facts

Active ingredient

Sodium Fluoride 0.0219% (0.01% w/v fluoride ion)

Purpose

Anticavity

Uses

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, cetylpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, disodium phosphate, blue 1

Questions?

1-800-285-9139

Dist. by Procter & Gamble,
Cincinnati OH 45202

www.crest.com

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

HELPS YOU GET

BETTER DENTAL
CHECK-UPS*

NEW!

Crest
PRO-HEALTH™

ANTICAVITY FLUORIDE RINSE

COMPLETE
WITH FLUORIDE - ALCOHOL FREE

*STRENGTHENS ENAMEL FOR A HEALTHIER MOUTH.

  • REBUILDS ENAMEL
  • HELPS PREVENT CAVITIES
  • CLEANS TEETH & GUMS
  • KILLS BAD BREATH GERMS
  • FRESHENS BREATH
  • NO BURNS OF ALCOHOL

FRESH MINT

Important: Read directions for proper use

1 L (33.8 FL OZ)

Principal Display Panel - 1 L Bottle Label
CREST PRO-HEALTH  COMPLETE (FRESH MINT)
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-003-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/201005/30/2015
2NDC:37000-003-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/201002/04/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/16/201005/30/2015
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 9/2016
Document Id: 3dab5b4b-f404-3391-e054-00144ff8d46c
Set id: 845fedd4-5391-4d58-8e50-67d549f95d74
Version: 2
Effective Time: 20160929
 
The Procter & Gamble Manufacturing Company