Colgate® Baking Soda and Peroxide Whitening Brisk Mint® Large Size Fluoride Toothpaste

COLGATE by

Drug Labeling and Warnings

COLGATE by is a Otc medication manufactured, distributed, or labeled by Mission Hills, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE  BAKING SODA AND PEROXIDE WHITENING BRISK MINT- sodium monofluorophosphate paste, dentifrice 
Mission Hills, S.A. de C.V.

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® Baking Soda and Peroxide Whitening Brisk Mint® Large Size Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of 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 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 130 g Carton

Colgate®
Fluoride Toothpaste

NET WT 4.6 OZ (130 g)

Baking Soda
& Peroxide
Whitening

Cleans Deep and
Whitens Teeth

Brisk Mint®Paste

PRINCIPAL DISPLAY PANEL - 130 g Cartonl
COLGATE   BAKING SODA AND PEROXIDE WHITENING BRISK MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65954-765
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 491.6 mg  in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-765-461 in 1 CARTON08/20/2011
1130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 65954-765-641 in 1 CARTON08/20/2011
2181 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 65954-765-821 in 1 CARTON08/20/2011
3232 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 65954-765-691 in 1 CARTON08/20/2011
4113 g in 1 TUBE; Type 0: Not a Combination Product
5NDC: 65954-765-751 in 1 CARTON08/20/2011
579 g in 1 TUBE; Type 0: Not a Combination Product
6NDC: 65954-765-601 in 1 CARTON08/20/2011
6170 g in 1 TUBE; Type 0: Not a Combination Product
7NDC: 65954-765-481 in 1 CARTON08/20/2011
7226 g in 1 TUBE; Type 0: Not a Combination Product
8NDC: 65954-765-581 in 1 CARTON08/20/2011
870 g in 1 TUBE; Type 0: Not a Combination Product
9NDC: 65954-765-921 in 1 CARTON08/20/2011
9141 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/20/2011
Labeler - Mission Hills, S.A. de C.V. (812312122)

Revised: 4/2019
Document Id: 7553b4b2-a04e-4f20-905f-dc2cb01fe01f
Set id: 40fa39f5-27a0-4d36-ad0a-fb2931e4b117
Version: 6
Effective Time: 20190403
 
Mission Hills, S.A. de C.V.