CREST GUM DETOXIFY PLUS WHITENING- stannous fluoride kit

Crest Gum Detoxify by

Drug Labeling and Warnings

Crest Gum Detoxify 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

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

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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)

INGREDIENTS AND APPEARANCE

CREST GUM DETOXIFY  PLUS WHITENING
stannous fluoride kit

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
ZINC LACTATE (UNII: 2GXR25858Y)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM GLUCONATE (UNII: R6Q3791S76)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		113 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	01/01/2018

Part 2 of 2

CREST  WHITENING GEL
other oral hygiene products gel, dentifrice

Product Information
Route of Administration	DENTAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		65 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
Cosmetic		01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)