COLGATE MAX CLEAN  SPEARMINT BLAST- sodium fluoride gel, dentifrice 
Mission Hills S.A de C.V
Reference Label Set Id: 260bd517-ec32-4e7f-92e1-032912053e0c

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 Clean™ Spearmint Blast® Fluoride Toothpaste

Active ingredient

Sodium fluoride 0.24% (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

Inactive ingredients

water, sorbitol, hydrated silica, PEG-12, poloxamer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, methylcellulose, mica, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

Questions?

1-800-468-6502
www.colgate.com/maxclean

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

Colgate®
Anticavity Fluoride Toothpaste

WITH WHITENING
MaxClean™
SMARTFOAM®

30% More Foam*
Cleans Tough to Reach Spaces

SPEARMINT BLAST®

NET WT 6.0 OZ (170 g)

Principal Display Panel - 170 g Tube Label
COLGATE MAX CLEAN   SPEARMINT BLAST
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-382
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) 347 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
Color GREEN Score     
Shape Size
Flavor SPEARMINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65954-382-85 1 in 1 CARTON
1 204 g in 1 TUBE
2 NDC:65954-382-60 1 in 1 CARTON
2 170 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 08/01/2011
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 7/2013
Document Id: edcebd1a-c533-4b59-aae7-1be68435d603
Set id: 9f401e77-7a7a-4f61-b80a-cf7f1461d76f
Version: 2
Effective Time: 20130716
 
Mission Hills S.A de C.V