CREST COMPLETE DEEP CLEAN- sodium fluoride paste, dentifrice

Crest Complete Deep Clean by

Drug Labeling and Warnings

Crest Complete Deep Clean by is a Otc medication manufactured, distributed, or labeled by Teresa Cecena DBA Genesis, Teresa Cecena, Procter & Gamble Manufacturera S de RL de CV, ROIR SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium fluoride .243%

PURPOSE

Anticavity toothpaste

INDICATIONS & USAGE

Help protect against cavities

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

WARNINGS

Keep out of reach of children under 6 years

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/22/2015

Labeler - Teresa Cecena DBA Genesis (078760958)

Registrant - Teresa Cecena (078760958)

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

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

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