Crest 3D White Whitening Therapy Enamel Care: Package Insert and Label Information

CREST 3D WHITE WHITENING THERAPY ENAMEL CARE- sodium fluoride paste, dentifrice
Procter & Gamble Manfuacturing 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% (0.16% w/v fluoride ion)

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

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, xanthan gum, sucralose, mica, titanium dioxide

Questions?

1-800-492-7378

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL — 116 g Carton

Crest ®

3D WHITE™

FLUORIDE ANTICAVITY

TOOTHPASTE

WHITENING

THERAPY

ENAMEL CARE

NET WT 4.1 OZ (116 g)

457
(click image for full-size original)
CREST 3D WHITE WHITENING THERAPY ENAMEL CARE
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-457
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
SACCHARIN SODIUM
HYDRATED SILICA
SODIUM LAURYL SULFATE
CARRAGEENAN
COCAMIDOPROPYL BETAINE
XANTHAN GUM
SUCRALOSE
TITANIUM DIOXIDE
GLYCERIN
HEXASODIUM HEXAMETAPHOSPHATE
POLYETHYLENE GLYCOL 300
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
MICA
Product Characteristics
Color white Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-457-41 1 TUBE in 1 CARTON contains a TUBE
1 116 g in 1 TUBE This package is contained within the CARTON (37000-457-41)
2 NDC:37000-457-85 1 TUBE in 1 CARTON contains a TUBE
2 24 g in 1 TUBE This package is contained within the CARTON (37000-457-85)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 07/12/2017
Labeler — Procter & Gamble Manfuacturing Company (004238200)

Revised: 01/2020 Procter & Gamble Manfuacturing Company

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