HANDY SOLUTIONS COLGATE CAVITY PROTECTION- sodium monofluorophosphate paste, dentifrice

Handy Solutions Colgate Cavity Protection by

Drug Labeling and Warnings

Handy Solutions Colgate Cavity Protection by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc, Colgate-Palmolive S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Handy Solutions Colgate Cavity Protection Toothpaste

Active ingredients:

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities.

Warnings

Keep out of the reach of children under 6 years 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 year of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
• Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
• Children under 2 years: Ask a dentist or physician.
  

Inactive ingredients:

dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin.

Questions or comments?

1-800-468-6502

Handy Solutions Colgate Cavity Protection Toothpaste

INGREDIENTS AND APPEARANCE

HANDY SOLUTIONS COLGATE CAVITY PROTECTION 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-132(NDC: 65954-060)
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-132-01	1 in 1 CARTON	08/21/2013
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 67751-132-02	1 in 1 CARTON	08/21/2013
2		53.87 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	08/16/2013

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-132) , repack(67751-132)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Hills S.A de C.V		812312122	manufacture(67751-132)