CREST COMPLETE DEEP CLEAN- sodium fluoride paste, dentifrice
Teresa Cecena DBA Genesis

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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Sodium fluoride .243%

Anticavity toothpaste

Help protect against cavities

Keep out reach of children under 6 Yrs of age. If more than used fro brushong is accidentally swallowed get medical help or poison control center right away

Direccions

adults and children 5 yrs and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
do not swallow
to minimiza swallowing use a pea-sized amount in children under 63
supervise children's brushing until good habits are established
children under 2 years as a dentist

sorbitol,water,hydrated silica, PED-6, sodium lauryl sulfate, flavor,zinc citrate,cellulose gum,carrageenan, soium saccharin, hydroxyethlcellulose,sodium citrate, stannoum chloride,chloride,polyyethylene,titanium dioxide,blue 1 lake

Keep out of reach of children under 6 years

CREST COMPLETE

CREST COMPLETE DEEP CLEAN
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69772-819
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.43 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ZINC CITRATE (UNII: K72I3DEX9B)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	white (With blue stripe and specs)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69772-819-01	1 in 1 CARTON	06/22/2015
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/22/2015

Labeler - Teresa Cecena DBA Genesis (078760958)

Registrant - Teresa Cecena (078760958)

Name	Address	ID/FEI	Business Operations
Establishment
Teresa Cecena DBA Genesis		078760958	relabel(69772-819)

Name	Address	ID/FEI	Business Operations
Establishment
Procter & Gamble Manufacturera S de RL de CV		812807550	manufacture(69772-819)

Name	Address	ID/FEI	Business Operations
Establishment
ROIR SA DE CV		812825434	relabel(69772-819)