Crest Aligner Care Cavity Defense

Crest Aligner Care by

Drug Labeling and Warnings

Crest Aligner Care 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 ALIGNER CARE CAVITY DEFENSE- stannous fluoride paste, dentifrice 
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 Aligner Care Cavity Defense

Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.14% 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

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
• this Crest is specially formulated to help prevent staining
• see your dentist regularly

Inactive ingredients

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

Questions?

1-888-399-0036

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel - 141 g tube in carton

Crest®

ALIGNER CARE

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

PROTECT MY SMILE

cavity defense toothpaste

ANTIBACTERIAL DEFENSE*

FOR PEOPLE WHO WEAR

ALIGNERS

RETAINERS

MOUTHGUARDS

*fights plaque bacteria associated with gingivitis

FRESH MINT

NET WT 4.1 OZ (116 g)

CREST ALIGNER CARE  CAVITY DEFENSE
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-929
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
SUCRALOSE (UNII: 96K6UQ3ZD4)
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)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-929-41	1 in 1 CARTON	01/04/2021
1		116 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	01/04/2021	08/16/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 8/2023

Document Id: 030e134e-ba5a-2f97-e063-6294a90a99ef

34390-5

Set id: c59812f6-1f4d-576f-e053-2a95a90a58dd

Version: 3

Effective Time: 20230816

 

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