Drug Facts

Active ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, antigingivitis toothpaste

Uses

aids in the prevention of cavities
helps prevent gingivitis
helps interfere with the harmful effects of plaque associated with gingivitis
helps control plaque bacteria that contribute to the development of gingivitis

Warning

Keep out of reach of children under 12 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 12 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
- do not swallow
children under 12 yrs. of age: ask a dentist

Other information

products containing stannous fluoride may produce surface staining of the teeth
adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
see your dentist regularly

Inactive ingredients

glycerin, hydrated silica, water, zinc lactate, sodium lauryl sulfate, trisodium phosphate, flavor, sodium gluconate, sodium saccharin, xanthan gum, cellulose gum, sodium hydroxide, polyethylene, mica, titanium dioxide, blue 1

Questions?

(800) 492-7378

Dist. by Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - Kit Carton

CLINICALLY PROVEN RESULTS IN ONE WEEK

Crest®
GUM DETOXIFY

+ WHITENING™

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND

ANTIGINGIVITIS/WHITENING GEL

STEP 1

6X Gum health
Improvement in one week*
*gingivitis improvement vs. ordinary toothpaste

STEP 2

Whiter teeth
in 1 week**
**improvement vs. ordinary toothpaste

1 TUBE NET WT 4.0 OZ (113 g) & 1 TUBE NET WT 2.3 OZ (65 g)

489

CREST GUM DETOXIFY PLUS WHITENING
stannous fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-489

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-489-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	01/01/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	113 g
Part 2	1 TUBE	65 g

Part 1 of 2

CREST GUM DETOXIFYING TREATMENT
stannous fluoride paste, dentifrice

Product Information
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
ZINC LACTATE (UNII: 2GXR25858Y)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM GLUCONATE (UNII: R6Q3791S76)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	01/01/2018

Part 2 of 2

CREST WHITENING GEL
other oral hygiene products gel, dentifrice

Product Information
Route of Administration	DENTAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	HYDROGEN PEROXIDE (UNII: BBX060AN9V)
INGR	SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
INGR	SUCRALOSE (UNII: 96K6UQ3ZD4)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		65 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	01/01/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Crest ® Gum Detoxify + Whitening ™