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 older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:65954-042
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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 (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
Color BLUE (LIGHT BLUE WITH WHITE FILM) Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65954-042-60 1 in 1 CARTON
1 170 g in 1 TUBE
2 NDC:65954-042-78 1 in 1 CARTON
2 221 g in 1 TUBE
3 NDC:65954-042-85 1 in 1 CARTON
3 204 g in 1 TUBE
4 NDC:65954-042-79 1 in 1 CARTON
4 79 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 01/27/2009
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 2/2013
Document Id: 35ef7565-f9d5-401f-aaad-b153ce9ea8ff
Set id: 5372cd99-37d7-4415-802b-0671d691ec86
Version: 2
Effective Time: 20130225
 
Mission Hills S.A de C.V