Drug Facts
Active ingredient
Stannous fluoride 0.454%
(0.14% w/v fluoride ion)
Crest Paste, Dentifrice
FDA Label NDC 69423-860
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 (NDC 69423-860). 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 drug facts, purposes, uses, otc - when using, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Anticavity, antigingivitis, antisensitivity toothpaste
Uses
- aids in the prevention of cavities
- helps prevent gingivitis
- helps interfere with the harmful effects of plaque associated with gingivitis
- helps control plaque bacteria that contribute to the development of gingivitis
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Otc - When Using
When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.
Otc - Stop Use
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.
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 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
- children under 12 yrs. of age: ask a dentist
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 Crest is specially formulated to help prevent staining
- see your dentist regularly
Inactive Ingredients
water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, carrageenan, flavor, sodium citrate, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, stannous chloride, charcoal powder, sucralose
Questions?
1-800-594-4158
Other
DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202
Principal Display Panel - 130 G Tube In Carton
Crest®
FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH
CAVITIES GINGIVITIS ENAMEL SENSITIVITY
PLAQUE TARTAR WHITENING FRESHENS BREATH
NET WT 4.6 OZ (130 g)
DENTIST DESIGNED
CLINICALLY PROVEN*
PRO HEALTH™
ADVANCED
STANNOUS FLUORIDE HELPS PREVENT PLAQUE
GROWTH TO STOP ISSUES BEFORE THEY START.**
WHITENING + CHARCOAL
Crest Pro Health Whitening + Charcoal (69423860.jpg)
* Please review the disclaimer below.
