Gel-kam Mint Gel, Dentifrice
FDA Label NDC 0126-0192

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Colgate Oral Pharmaceuticals, Inc. for the product Gel-kam Mint (NDC 0126-0192). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purposes, uses, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purposes

→ Uses

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

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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)