Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameSTANNOUS FLUORIDE
Labeler / manufacturerColgate-Palmolive Company
RouteDENTAL
Drug classDrug class not supplied in source label
Product NDC35000-431
Label effective date2026-08-21
Official product label reference
Colgate Total Active Prevention Clean Mint — Colgate-Palmolive Company
This page contains 12 source sections for STANNOUS FLUORIDE, dental route. Label set 178d4535-fa57-4b53-b1f8-5c591f2ea9e7, version 3.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses aids in the prevention of cavities helps prevent gingivitis helps interfere with harmful effects of plaque associated with gingivitis builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Directions adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth. do not swallow. children under 12 years of age: consult a dentist.
Warnings
Warnings When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist. Stop use and ask a dentist if the sensitivity 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. Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
Unclassified section
Drug Facts
Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022 U.S.A.
Active ingredient
Active ingredient Stannous Fluoride 0.454% (0.15% w/v fluoride ion)
While using this medicine
When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.
When to stop use and seek help
Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
Child safety
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.
Storage and handling
Other information products containing stannous fluoride 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. this Colgate product is specially formulated to help prevent staining.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.