CREST- sodium fluoride paste, dentifrice

Crest by

Drug Labeling and Warnings

Crest by is a Otc medication manufactured, distributed, or labeled by Buzz Export Services Pty., Ltd., Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Sodium fluoride 0.243% (0.15% 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

water, sorbitol, hydrated silica, disodium pyrophosphate, xylitol, flavor, sodium hydroxide, cellulose gum, cocamidopropyl betaine, sodium laureth-2 phosphate, sodium saccharin, xanthan gum, carbomer, sucralose, polyethylene oxide, polyethylene, mica, titanium dioxide, blue 1 lake

Questions?

1-800-959-6586

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati, OH 45202

Package Labeling

Kit Package:

INGREDIENTS AND APPEARANCE

CREST 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69491-831(NDC: 37000-831)
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)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURETH-2 PHOSPHATE (UNII: 1IO8CC3XDG)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLYETHYLENE OXIDE 900000 (UNII: 16P9295IIL)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-831-01	1 in 1 CARTON
1		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	12/23/2014

Labeler - Buzz Export Services Pty., Ltd. (747317902)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.		421290194	repack(69491-831)