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Gel-Kam Mint

Dosage form: gel, dentifrice
Ingredients: Stannous Fluoride 4mg in 1g
Labeler: Colgate Oral Pharmaceuticals, Inc.
NDC Code: 0126-0192

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.

Gel-Kam®

Drug Facts

Active ingredient

Stannous fluoride 0.4% (w/w)

Purposes

Anticavity/Sensitivity Relief

Uses
  • helps protect against cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

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
  • adults and children 12 years of age or older: use after regular brushing and flossing
  • shake excess water from your toothbrush and cover bristles with gel
  • brush thoroughly
  • keep on your teeth for one minute and then spit out
  • do not swallow
  • do not rinse, eat or drink for 30 minutes
  • use once a day for cavity protection
  • use twice a day (morning and evening) for sensitivity relief or as recommended by a dentist or physician
  • make sure all sensitive areas are covered by using a toothbrush or a cotton swab
  • supervise children until capable of using without supervision
  • children under 12 years of age: consult a dentist or physician

Other information
  • this is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before use
  • this product may produce surface staining of the teeth Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • do not use if embossed seal on tube is broken or missing
  • to open tube, remove cap and pierce foil seal with point of cap
  • keep tightly closed when not in use
  • store at controlled room temperature 68-77°F (20-25°C)

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 - 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)

GEL-KAM MINT 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0192
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (Fluoride Ion) Fluoride Ion4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0126-0192-931 TUBE in 1 CARTON
1122 g in 1 TUBE
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 AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (Fluoride Ion) Fluoride Ion4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0126-0165-931 TUBE in 1 CARTON
1122 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1990
Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

 
Colgate Oral Pharmaceuticals, Inc.

Medically reviewed on Nov 29, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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