Tween Crest® Cavity Protection

Tween Crest by

Drug Labeling and Warnings

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

Drug Details [pdf]

TWEEN CREST CAVITY PROTECTION- sodium 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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Tween
Crest®

Cavity Protection

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warning

Keep out of reach of children under 6 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 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
• children under 2 yrs.: ask a dentist

Inactive ingredients

sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, sodium hydroxide, flavor, sodium saccharin, xanthan gum, carbomer, mica, titanium dioxide, blue 1

Questions?

1-800-594-4158

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

9+ YEARS

TWEEN

Crest®

FLUORIDE ANTICAVITY TOOTHPASTE

FIGHTS CAVITIES STRENGTHENS ENAMEL

CaVITY

PR oTECTION

NET WT 4.2 OZ (119 g)

MINTY BREEZE

TWEEN CREST  CAVITY PROTECTION
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-886
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)

Product Characteristics
Color	blue (Clear gel)	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-886-42	1 in 1 CARTON	07/26/2017
1		119 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	07/26/2017	11/26/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2019

Document Id: 8bc5a99a-5966-af3e-e053-2a95a90af6f5

34390-5

Set id: 54d8932d-98fe-4fcf-e054-00144ff8d46c

Version: 2

Effective Time: 20190620

 

The Procter & Gamble Manufacturing Company