CREST 3D WHITE WHITENING THERAPY ENAMEL CARE- sodium fluoride paste, dentifrice

Crest 3D White Whitening Therapy by

Drug Labeling and Warnings

Crest 3D White Whitening Therapy by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manfuacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARRAGEENAN (UNII: 5C69YCD2YJ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-457-41	1 in 1 CARTON	07/12/2017
1		116 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-457-85	1 in 1 CARTON	07/12/2017
2		24 g in 1 TUBE; Type 0: Not a Combination Product

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)