HANDY SOLUTIONS CREST CAVITY PROTECTION FLUORIDE ANTICAVITY- sodium fluoride paste, dentifrice

Handy Solutions Crest Cavity Protection FLUORIDE ANTICAVITY by

Drug Labeling and Warnings

Handy Solutions Crest Cavity Protection FLUORIDE ANTICAVITY by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Handy Solutions Crest Cavity Protection FLUORIDE ANTICAVITY TOOTHPASTE

Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

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, sodium lauryl sulfate, trisodium phosphate, flavor, sodium phosphate, cellulose gum, carbomer, sodium saccharin, titanium dioxide, blue 1

Questions or comments?

call toll-free 1-800-492-7378

Handy Solutions Crest Cavity Protection FLUORIDE ANTICAVITY TOOTHPASTE

Handy Solutions Crest Cavity Protection FLUORIDE ANTICAVITY TOOTHPASTE 0.85oz/24g (67751-052-01)

Handy Solutions Crest Cavity Protection FLUORIDE ANTICAVITY TOOTHPASTE 0.85oz/24g (67751-052-02)

INGREDIENTS AND APPEARANCE

HANDY SOLUTIONS CREST CAVITY PROTECTION FLUORIDE ANTICAVITY 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-052(NDC:37000-005)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-052-01	1 in 1 TUBE	08/21/2013
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 67751-052-02	1 in 1 PACKAGE	08/21/2013
2		24 g 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	06/24/2013

Labeler - Navajo Manufacturing Company Inc (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc		136941411	relabel(67751-052) , repack(67751-052)