FDA Label for Gel-kam Fruit And Berry
View Indications, Usage & Precautions
Gel-kam Fruit And Berry Product Label
The following document was submitted to the FDA by the labeler of this product Colgate Oral Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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
Otc - Do Not Use
Do not use this product longer than four weeks for sensitive teeth unless recommended by a dentist or physician.
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
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)
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