Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope

Active ingredient

Sodium fluoride 0.243%

Purpose

Anti-Cavity toothpaste

Use

helps protect against cavities

Warnings

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. and 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 years : ask a dentist

Inactive ingredients

Sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol (0.7%), xanthan gum, sodium saccharin, glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

Questions or comments?

call toll-free 1-800-492-7378

PDP

129803 129159 129804

HANDY SOLUTIONS CREST COMPLETE MULTI-BENEFIT WHITENING PLUS SCOPE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67751-095(NDC:58933-020)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg in 1 g

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67751-095-01	1 in 1 PACKAGE	08/21/2013
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:67751-095-03	1 in 1 PACKAGE	08/21/2013
2		43 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:67751-095-04	1 in 1 PACKAGE	08/21/2013
3		113 g 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 Drug	M021	08/16/2013

Labeler - Navajo Manufacturing Company Inc (091917799)

Name	Address	ID/FEI	Business Operations
Establishment
THE PROCTER & GAMBLE MANUFACTURING COMPANY		005279245	manufacture(67751-095)

Name	Address	ID/FEI	Business Operations
Establishment
Navajo Manufacturing Company Inc		136941411	relabel(67751-095) , repack(67751-095)