HANDY SOLUTIONS COLGATE CAVITY PROTECTION- sodium monofluorophosphate paste, dentifrice
Navajo Manufacturing Company Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Colgate Toothpaste Colgate Toothpaste/Toothbrush kit

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/16/2013	06/30/2018

Labeler - Navajo Manufacturing Company Inc. (091917799)

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

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

Revised: 3/2023

Document Id: f6f7d2f0-9d9d-4b58-e053-6294a90acea1

Set id: 37dbb9b4-e308-4d2e-8602-6888e4077359

Version: 6

Effective Time: 20230315

Navajo Manufacturing Company Inc.