CREST ANTI-CAVITY- sodium fluoride paste, dentifrice

CREST ANTI-CAVITY by

Drug Labeling and Warnings

CREST ANTI-CAVITY by is a Otc medication manufactured, distributed, or labeled by GENESIS IMPORTS & EXPORTS LLC, genesis imports & exports llc, Procter & Gamble Manufactura, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Sodium fluoride .243% (.15% w/v flouride ion)

PURPOSE

Purpose

Anticavity toothpaste

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS

kEEEP OUT OF REACH OF CHILDREN UNDER 6 YRS OF AGE

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE CHILDREN UNDER 6 YRS OF AGE.

If more than used for brishing is accidentally swallowed, get medical help or contact a poison control center rigth away.

DOSAGE & ADMINISTRATION

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-sides amount in children under 6
• supervise children's brushiong until goog habits are established
• children under 2 yrs ask a dentist

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

sorbitol,water,hydrated silica, sodium lauryl sulfate, trisosium phosphate, flavor, sodium phospahte, cellulose gum, sodium saccharin, carbomer, titanium dioxide

INDICATIONS & USAGE

USE

Helps protect against cavities

WARNINGS

KEEP OUT OF REACH OF CHILDREN UNDER 6 YTS OF AGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CREST ANTI-CAVITY 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-130
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.45 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EUGENOL (UNII: 3T8H1794QW)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69772-130-01	1 in 1 CARTON	03/31/2017
1		100 mL 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	03/31/2017

Labeler - GENESIS IMPORTS & EXPORTS LLC (078760958)

Registrant - GENESIS IMPORTS & EXPORTS LLC (078760958)

Establishment
Name	Address	ID/FEI	Business Operations
genesis imports & exports llc		078760958	relabel(69772-130)

Establishment
Name	Address	ID/FEI	Business Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.		812807550	manufacture(69772-130)