Gel-kam®

Gel-kam®
SPL v13
SPL
SPL Set ID 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c
Route
DENTAL
Published
Effective Date 2018-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Glycerin Hydroxyethyl Cellulose, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1990-01-01

Description

Drug Facts

Purpose

Anticavity/Sensitivity Relief


Medication Information

Purpose

Anticavity/Sensitivity Relief

Description

Drug Facts

Uses
  • helps protect against cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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.

Section 50570-1

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

Purposes

Anticavity/Sensitivity Relief

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
Active Ingredient

Stannous fluoride 0.4% (w/w)

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)


Structured Label Content

Uses
  • helps protect against cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50570-1 (50570-1)

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

Purposes

Anticavity/Sensitivity Relief

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
Active Ingredient (Active ingredient)

Stannous fluoride 0.4% (w/w)

Other Information (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 (Inactive ingredients)

flavor, glycerin, hydroxyethylcellulose

Questions Or Comments? (Questions or comments?)

call toll free at 1-800-962-2345

Principal Display Panel 122 G Tube Carton Mint (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 (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)


Advanced Ingredient Data


Raw Label Data

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