CREST PRO-HEALTH WHITENING- whitening gel, dentifrice

Crest Pro-Health by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.14% w/v fluoride ion)

Purposes

Anticavity, antigingivitis, antisensitivity 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

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

Warnings

When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.

Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care.

Keep out of reach of children. 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. & older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist.

Make sure to brush all sensitive areas of the teeth.

do not swallow

children under 12 yrs.: 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

this Crest is specially formulated to help prevent staining

see your dentist regularly

INACTIVE INGREDIENT

water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, carrageenan, flavor, sodium citrate, xanthan gum, zinc citrate, sodium hydroxide, stannous chloride, sodium saccharin, sucralose, mica, titanium dioxide, blue 1

QUESTIONS

Questions? 1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Crest Pro Health Whitening 178 g carton

Crest®

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

CAVITIES GUM ENAMEL SENSITIVITY PLAQUE TARTAR WHITENING FRESHENS BREATH

NET WT 6.3 OZ (178 g)

PRO-HEALTH™

PROTECTS 100% OF THE WHOLE MOUTH*

WHITENING

*Reaches 100% of mouth surfaces and protects against plaque bacteria that lead to gingivitis

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  WHITENING
whitening gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-876
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM GLUCONATE (UNII: R6Q3791S76)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC CITRATE (UNII: K72I3DEX9B)
MICA (UNII: V8A1AW0880)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-876-46	1 in 1 CARTON	01/01/2022
1		130 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69423-876-63	1 in 1 CARTON	01/01/2022
2		178 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69423-876-33	1 in 1 CARTON	01/01/2022
3		93 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 69423-876-24	1 in 1 CARTON	01/01/2022
4		24 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 69423-876-86	2 in 1 CARTON	01/01/2022
5		121 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 69423-876-59	1 in 1 CARTON	01/01/2022
6		167 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 Drug	M022	01/01/2022

Labeler - The Procter & Gamble Manufacturing Company (004238200)