GEL-KAM MINT- stannous fluoride gel, dentifrice 
GEL-KAM FRUIT AND BERRY- stannous fluoride gel, dentifrice 
Colgate Oral Pharmaceuticals, Inc.

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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Gel-Kam®

Drug Facts

Active ingredient

Stannous fluoride 0.4% (w/w)

Purposes

Anticavity/Sensitivity Relief

Uses

Warnings

Do not use this product longer than four weeks for sensitive teeth unless recommended by a dentist or physician.

Stop use and ask a doctor if problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

flavor, glycerin, hydroxyethylcellulose

Questions or comments?

call toll free at 1-800-962-2345

PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Mint

NDC 0126-0192-93

Colgate®

Gel•Kam®

0.4% Stable Stannous Fluoride
PREVENTATIVE TREATMENT GEL
For Cavity Protection and Sensitive Teeth
MINT

NET WT 4.3 OZ (122 g)

PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Mint

PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Fruit and Berry

NDC 0126-0165-93

Colgate®

Gel•Kam®

0.4% Stable Stannous Fluoride
PREVENTATIVE TREATMENT GEL
For Cavity Protection and Sensitive Teeth
FRUIT & BERRY

NET WT 4.3 OZ (122 g)

PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Fruit and Berry
GEL-KAM MINT 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0192
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0126-0192-931 in 1 CARTON01/01/1990
1122 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/1990
GEL-KAM FRUIT AND BERRY 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0165
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0126-0165-931 in 1 CARTON01/01/1990
1122 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/1990
Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

Revised: 12/2019
Document Id: 66a0a83f-733a-4ea5-9ef2-e81638f8013f
Set id: 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c
Version: 5
Effective Time: 20191209
 
Colgate Oral Pharmaceuticals, Inc.