Other
Drug Facts
Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 U.S.A.
Colgate Sensitive Prevent And Repair Paste, Dentifrice
FDA Label NDC 35000-128
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-palmolive Company for the product Colgate Sensitive Prevent And Repair (NDC 35000-128). 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, otc - purpose, uses, otc - when using, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Potassium Nitrate 5% | Antisensitivity |
| Sodium Fluoride 0.24% (0.14% w/v fluoride ion) | Anticavity |
Uses
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
- helps protect against cavities
Otc - When Using
When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
Otc - Stop Use
Stop use and ask a dentist if the 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 and older | apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. |
| children under 12 years | consult a dentist or physician |
Inactive Ingredients
Water, Glycerin, Hydrated Silica, Sorbitol, PEG-12, PVM/MA Copolymer, Sodium Lauryl Sulfate, Flavor, Trisodium Phosphate, Poloxamer 407, Sodium Hydroxide, Sodium Saccharin, Cellulose Gum, Xanthan Gum, Titanium Dioxide.
Questions?
1-800-468-6502
Principal Display Panel - 170 G Tube Carton
Colgate®
Anticavity Toothpaste for Sensitive Teeth
ADVANCED DUAL ACTION FORMULA
HELPS ✔ PREVENT SENSITIVITY ✔ REPAIR WEAKENED ENAMEL
MAXIMUM STRENGTH*
Sensitive
PREVENT & REPAIR
+ WHITENING
NET WT 6.0 OZ (170 g)
GENTLE MINT
paste
Principal Display Panel (170 g Tube Carton)
* Please review the disclaimer below.
