Colgate Total Clean Mint ANTIGINGIVITIS TOOTHPASTE

Colgate Total Clean Mint ANTIGINGIVITIS by

Drug Labeling and Warnings

Colgate Total Clean Mint ANTIGINGIVITIS by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc, Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE TOTAL CLEAN MINT ANTIGINGIVITIS- sodium fluoride paste, dentifrice 
Navajo Manufacturing Company Inc

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Colgate Total Clean Mint ANTIGINGIVITIS TOOTHPASTE

Colgate Total Clean Mint ANTIGINGIVITIS TOOTHPASTE

Active ingredients

Sodium Fluoride 0.24% (0.14% W/V Fluoride Ion)
Triclosan 0.30%

Purpose

Anticavity
Antigingivitis

Uses

Aids in the prevention of:

• cavities
• plaque
• gingivitis

Warning

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.

Ask a dentist before use if you have

• bleeding or redness lasting more than 2 weeks
• pain, swelling, pus, loose teeth, or more spacing between teeth

These may be signs of peridontitis , a serious form of gum disease.

Directions

supervise children as necessary until capable of using without supervision.

• adults and children 6 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
• children under 12 years: instruct in good brushing and rinsing habits ; (to minimize swallowing)
• children under 6 years: do not use unless directed by a dentist or a physician

Antiplaque and antigingivitis use not proven in children.

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, carrageenan, propylene glycol, sodium saccharin, titanium dioxide.

Questions? Comments?

Call toll-free 1-800-468-6502 or visit www.colgate.com

Principal Display Panel

COLGATE TOTAL CLEAN MINT ANTIGINGIVITIS 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-131
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.14 g  in 100 g
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-131-01	1 in 1 PACKAGE	06/20/2017	01/01/2020
1		21.2 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
NDA	NDA020231	06/24/2013	01/01/2020

Labeler - Navajo Manufacturing Company Inc (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive Company		068693167	manufacture(67751-131)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc		136941411	relabel(67751-131) , repack(67751-131)

Revised: 11/2019

Document Id: 97521927-60ac-6b20-e053-2a95a90ae353

34390-5

Set id: 91b607d3-43e9-4256-8ec0-42c2fd25106a

Version: 6

Effective Time: 20191114

 

Navajo Manufacturing Company Inc