Colgate® Max White® Crystal Mint 6.0 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  MAX WHITE CRYSTAL MINT- sodium fluoride gel, dentifrice 
Mission Hills S.A de C.V
Reference Label Set Id: 2a742816-f5e9-427a-86fd-d728408e4aa4
Reference Label Set Id: c12ca704-951f-436d-8a6b-18494e149d80

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® Max White® Crystal Mint 6.0 Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% 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

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1, FD&C yellow no. 5

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

FRESHENS BREATH
MaxWhite®
WITH
MINI
BRIGHT STRIPS

Whitens to Help Teeth Stay Bright*

NET WT 6.0 OZ (170 g)

CRYSTAL MINT

Principal Display Panel - 170 g Tube Carton
COLGATE   MAX WHITE CRYSTAL MINT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65954-042
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R) 564.38 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorBLUE (LIGHT BLUE WITH WHITE FILM) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-042-601 in 1 CARTON01/27/2009
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 65954-042-781 in 1 CARTON01/27/2009
2221 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 65954-042-851 in 1 CARTON01/27/2009
3204 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 65954-042-791 in 1 CARTON01/27/2009
479 g in 1 TUBE; Type 0: Not a Combination Product
5NDC: 65954-042-581 in 1 CARTON01/27/2009
570 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/27/2009
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019
Document Id: 674b1b08-0911-4ab3-b651-d359c786f9c9
Set id: 5372cd99-37d7-4415-802b-0671d691ec86
Version: 4
Effective Time: 20190410
 
Mission Hills S.A de C.V