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Drug Facts
Dist. by Procter & Gamble, Cincinnati, OH 45202
Crest Pro-health Paste, Dentifrice
FDA Label NDC 84126-639
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Crest Pro-health (NDC 84126-639). 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% | Toothpaste for sensitive teeth |
| Sodium fluoride 0.243% (0.14% w/v fluoride ion) | Toothpaste for cavity prevention |
Uses
- when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
- aids in the prevention of cavities
Otc - When Using
When using this productdo not use longer than four weeks unless recommended by a dentist.
Otc - Stop Use
Stop use and ask a dentist ifproblem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.
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
- 12 yrs. & 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. Make sure to brush all sensitive areas of the teeth.
- do not swallow
- do not use in children under 12 yrs.
Inactive Ingredients
water, hydrated silica, glycerin, sorbitol, sodium lauryl sulfate,
trisodium phosphate, flavor, cellulose gum, alcohol (0.7%), sodium saccharin, xanthan
gum, polysorbate 80, cetylpyridinium chloride, titanium dioxide, blue 1
Questions?
1-800-492-7378
Principal Display Panel - 170 G Tube Carton
Crest
PRO-HEALTH
NET WT
5.1 0Z (144 g)
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PROTECTION
DENTIST DESIGNED
CLINICALLY PROVEN
+ WHITENING
SENSITIVITY RELIEF
Maximum strength** sensitivity relief
MINTY FRESH SCOPE
* Please review the disclaimer below.
