Crest ® Pro-Health ® [HD]™ Trial/Travel size

Crest Pro-Health HD by

Drug Labeling and Warnings

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

Drug Details [pdf]

CREST PRO-HEALTH HD- stannous fluoride 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Crest ® Pro-Health ® [HD]™
Trial/Travel size

Drug Facts

Active ingredient

Stannous fluoride 0.454% (0.15% 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. 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

TRY ME: TRIAL SIZE

Crest®

PRO-HEALTH™

[HD]™

FLUORIDE TOOTHPASTE FOR ANTICAVITY,
ANTIGINGIVITIS AND SENSITIVE TEETH
& WHITENING GEL

6X HEALTH IMPROVEMENT*

6X WHITENING IN 1 WEEK**

2-STEP SYSTEM

*gingivitis improvement vs. ordinary toothpaste
**improvement vs. ordinary toothpaste

1 TUBE NET WT 0.85 OZ (24 g) &
1 TUBE NET WT 0.68 OZ (19 g)

CREST PRO-HEALTH HD 
stannous fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-038

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-038-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	01/30/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	24 g
Part 2	1 TUBE	19 g

Part 1 of 2

CREST PRO-HEALTH HD STEP 1  PURIFYING CLEANSER
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)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	03/15/2014

Part 2 of 2

CREST PRO-HEALTH HD STEP 2  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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		19 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		03/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/30/2017	06/20/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2019

Document Id: 8bc25ff2-72ee-77e6-e053-2a95a90a5463

34390-5

Set id: 4756dfd8-aa21-44eb-e054-00144ff88e88

Version: 2

Effective Time: 20190620

 

The Procter & Gamble Manufacturing Company