CREST EXPRESSIONS SCOPE- sodium fluoride paste, dentifrice

Crest Expressions Scope by

Drug Labeling and Warnings

Crest Expressions Scope by is a Otc medication manufactured, distributed, or labeled by Teresa Cecena DBA Genesis Imports, Teresa Cecena, Teresa Cecena DBA Genesis, procter & gamble manufactura s. de r.l. de cv. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Sodium Fluoride

PURPOSE

PURPOSE

Anticavity toothpaste

WARNINGS

WARNINGS

kEEP OUT OF REACH OF CHILDREN UNDER 6 YRS OF AGE.IF MORE THAT USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL VENTER RIGHT AWAY.

INDICATIONS & USAGE

DIRECTIONS

• Adults and children 2 yrs. & older; brush teeth thoroughly after meals or at least twice a day or use as directed 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 INGREDIENT

sorbitol,water,hydrated silica,disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol, xanthan gum, sodium saccharin , glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cethylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

QUESTIONS

QUESTIONS?

1-800-492-7378

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS

DOSAGE & ADMINISTRATION

DIRECTION

Adults and childreen 2 yrs and older ; brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CREST EXPRESSIONS SCOPE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-820
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	243 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ALCOHOL (UNII: 3K9958V90M)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69772-820-01	100 g in 1 TUBE; Type 0: Not a Combination Product	01/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/28/2016

Labeler - Teresa Cecena DBA Genesis Imports (078760958)

Registrant - Teresa Cecena (078760958)

Establishment
Name	Address	ID/FEI	Business Operations
Teresa Cecena DBA Genesis		078760958	relabel(69772-820)

Establishment
Name	Address	ID/FEI	Business Operations
procter & gamble manufactura s. de r.l. de cv		812807550	manufacture(69772-820)