Colgate® Total™ WHITENING ALCOHOL FREE MOUTHWASH

Drug Labeling and Warnings

Drug Details [pdf]

COLGATE TOTAL  WHITENING SPARKLEMINT- cetylpyridinium chloride mouthwash 
Colgate Oral Pharmaceuticals

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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Colgate®
Total™
WHITENING
ALCOHOL FREE MOUTHWASH

Use

Offers effective and safe whitening of teeth.

Warnings

Do not use this product for more than 4 weeks.

Keep out of reach of children under 12 years of age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Do not use in case you have hypersensitivity to the formula components. In case of irritation and/or unpleasant reactions, stop using immediately.

Directions

In the morning, rinse for 60 seconds using 15 mL (3 teaspoons) of mouthwash before and after brushing. Repeat this procedure at night.

Children under 12 years of age: do not use

Other information

Store at controlled room temperature 20-25° C(68-77° F)

Use only as indicated above.

Ingredients

water, sorbitol, propylene glycol, hydrogen peroxide, poloxamer 338, polysorbate 20, methyl salicylate, menthol, sodium saccharin, FD&C blue no. 1

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 Made in U.S.A.

Questions or comments?

Call toll-free: 1-800-468-6502

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Colgate®

Total™

WHITENING
ALCOHOL FREE MOUTHWASH

Effectively
Whitens Teeth

Freshens Breath

CLINICALLY TESTED

SPARKLEMINT

30 FL OZ (1.87 PT) 887 mL

10001492

Principal Display Panel - 30 mL Bottle Label
COLGATE TOTAL   WHITENING SPARKLEMINT
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0126-0026
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE10.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Hydrogen Peroxide (UNII: BBX060AN9V)  
Poloxamer 338 (UNII: F75JV2T505)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Menthol, unspecified form (UNII: L7T10EIP3A)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0126-0026-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201008/01/2019
2NDC: 0126-0026-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201008/01/2019
3NDC: 0126-0026-14887 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201008/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/201008/01/2019
Labeler - Colgate Oral Pharmaceuticals (968801118)

Revised: 9/2019
Document Id: 8041763b-865a-4fa9-991c-088800e335e3
Set id: 7ae1abdb-09e0-41ec-9446-c718bfe80ca2
Version: 2
Effective Time: 20190910