COLGATE  MAX CLEAN EFFERVESCENT MINT- sodium fluoride gel, 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.

----------

Colgate® Max Clean™ Effervescent mint™ Fluoride Toothpaste

Drug Facts

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

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

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

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

MaxClean™
with WHITENING

NET WT 6.0 OZ (170 g)
EFFERVESCENT MINT

SmartFoam®
30% MORE FOAM*
CLEANS TOUGH TO REACH SPACES

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
COLGATE   MAX CLEAN EFFERVESCENT MINT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-381
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) 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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLCELLULOSE (400 MPA.S) (UNII: O0GN6F9B2Y)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-381-011 in 1 CARTON03/18/2011
128.3 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:65954-381-601 in 1 CARTON03/18/2011
2170 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:65954-381-851 in 1 CARTON03/18/2011
3204 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:65954-381-781 in 1 CARTON03/18/2011
4221 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/18/2011
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 3/2018
Document Id: 155b7309-d46d-489f-bc2a-3c5097462709
Set id: 649caacc-b81e-4a94-9cc3-69f5d378caef
Version: 5
Effective Time: 20180327
 
Mission Hills S.A de C.V