Crest Complete Multi-Benefit Whitening Plus Herbal Mint Expressions: Package Insert and Label Information

CREST COMPLETE MULTI-BENEFIT WHITENING PLUS HERBAL MINT EXPRESSIONS- sodium fluoride paste, dentifrice
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

Sodium fluoride 0.243%

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children’s brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

sorbitol, water, hydrated silica, flavor, disodium pyrophosphate, sodium lauryl sulfate, sodium saccharin, sodium hydroxide, carbomer, xanthan gum, cellulose gum, titanium dioxide, mica, blue 1, yellow 5, yellow 6

Questions?

1-800-285-3213

Dist. by Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL — 170 g Tube Carton

Fights Cavities, Whitens + Bold Mint Flavor

Crest ®
complete MULTI-BENEFITâ„¢

FLUORIDE TOOTHPASTE

NET WT 6.0 OZ (170 g)

WHITENING+

HERBAL MINT
EXPRESSIONS

extreme herbal mint

Principal Display Panel -- 170 g Tube Carton
(click image for full-size original)
CREST COMPLETE MULTI-BENEFIT WHITENING PLUS HERBAL MINT EXPRESSIONS
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-825
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL
WATER
HYDRATED SILICA
SODIUM ACID PYROPHOSPHATE
SODIUM LAURYL SULFATE
SACCHARIN SODIUM
SODIUM HYDROXIDE
XANTHAN GUM
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
TITANIUM DIOXIDE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
ALUMINUM OXIDE
Product Characteristics
Color WHITE (with green stripe) Score
Shape Size
Flavor SPEARMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-825-06 1 TUBE in 1 CARTON contains a TUBE
1 170 g in 1 TUBE This package is contained within the CARTON (37000-825-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 07/01/2011
Labeler — Procter & Gamble Manufacturing Company (004238200)

Revised: 01/2016 Procter & Gamble Manufacturing Company

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