Drug Facts
Active ingredient
Stannous fluoride 0.454%
(0.15% w/v fluoride ion)
Crest Paste, Dentifrice
FDA Label NDC 84126-674
11 label sections · Submitted to the FDA by The Procter & Gamble Manufacturing Company · 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 84126-674). 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 - stop use, otc - keep out of reach of children, directions, other information, inactive ingredients, 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 - 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.
• pain/sensitivity still persists after 4 weeks of use. • 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 or symptoms of periodontitis, a serious form of gum disease.
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, flavor, carrageenan, sodium citrate, xanthan gum, zinc citrate, sodium hydroxide, stannous chloride, sodium saccharin, sucralose, titanium dioxide
Questions?
1-800-492-7378
Other
DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202
Principal Display Panel - 144 G Tube In Carton
ENAMEL PROTECTION
Crest
FAST-ACTING &
24hr
PROTECTION*
DENTIST DESIGNED. CLINICALLY PROVEN.†
SENSITIVITY
RELIEF
Strengthens & repairs
weakend enamel
Treats the root
cause of sensitivity
NET WT
5.1 OZ (144 g)
FLUORIDE TOOTHPASTE FOR ANTICAVITY,
ANTIGINGIVITIS AND HYPERSENSITIVE TEETH
FRESH BREATH
COOL MINT
* Please review the disclaimer below.
