Crest 3D White Ultra Vivid Mint: Package Insert and Label Information

CREST 3D WHITE ULTRA VIVID MINT- sodium fluoride paste, dentifrice
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.

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warning

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

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, sodium saccharin, carbomer, polysorbate 80, mica, titanium dioxide, blue 1

Questions?

1-800-492-7378

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL — 147 g Tube Carton

IMPROVED FORMULA

Crest ®

3D WHITE™
FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 5.2 OZ (147 g)

ENAMEL SAFE WHITENING

Removes up to 90 % of surface stains

STARTS WHITENING AFTER 1 BRUSH
VIVID MINT

ULTRA

69423850
(click image for full-size original)
CREST 3D WHITE ULTRA VIVID MINT
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-850
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
SORBITOL
HYDRATED SILICA
SODIUM ACID PYROPHOSPHATE
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
SODIUM HYDROXIDE
SACCHARIN SODIUM
CARBOXYPOLYMETHYLENE
MICA
TITANIUM DIOXIDE
FD&C BLUE NO. 1
POLYSORBATE 80
Product Characteristics
Color blue Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69423-850-52 1 TUBE in 1 CARTON contains a TUBE
1 147 g in 1 TUBE This package is contained within the CARTON (69423-850-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 12/01/2021
Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 09/2021 The Procter & Gamble Manufacturing Company

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