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 Type HUMAN OTC DRUG Item Code (Source) NDC:0126-0026
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 10.5 mg  in 20 mL
Product Characteristics
Color BLUE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0126-0026-08 236 mL in 1 BOTTLE
2 NDC:0126-0026-16 473 mL in 1 BOTTLE
3 NDC:0126-0026-14 887 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/01/2010
Labeler - Colgate Oral Pharmaceuticals (055002195)

Revised: 7/2010
Document Id: a02bd250-d064-4ccc-9135-c8a3306e79f4
Set id: 7ae1abdb-09e0-41ec-9446-c718bfe80ca2
Version: 1
Effective Time: 20100715
 
Colgate Oral Pharmaceuticals