CREST 3D WHITE- sodium fluoride paste, dentifrice

Crest 3D White by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.16% 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

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

Questions?

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

Crest®
3D WHITE
LUXE ®

FLUORIDE ANTICAVITY
TOOTHPASTE

GLAMOROUS
WHITE ®

REMOVES UP TO 95% OF SURFACE STAINS
IN 3 DAYS & PROTECTS AGAINST FUTURE STAINS

VIBRANT MINT

NET WT 3.5 OZ (99 g)

INGREDIENTS AND APPEARANCE

CREST 3D WHITE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-852
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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARRAGEENAN (UNII: 5C69YCD2YJ)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-852-01	1 in 1 CARTON	02/04/2014	07/12/2017
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-852-04	1 in 1 CARTON	02/04/2014
2		116 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-852-05	1 in 1 CARTON	02/04/2014	07/12/2017
3		156 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 37000-852-35	1 in 1 CARTON	02/04/2014
4		99 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 37000-852-48	1 in 1 CARTON	02/04/2014	06/19/2019
5		136 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 37000-852-07	2 in 1 CELLO PACK	02/04/2014	06/19/2019
6		1 in 1 CARTON
6		99 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 37000-852-82	2 in 1 CELLO PACK	02/04/2014
7		1 in 1 CARTON
7		116 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	02/04/2014

Labeler - The Procter & Gamble Manufacturing Company (004238200)