Drug Facts
Active ingredient
Stannous fluoride 0.454%
(0.15% w/v fluoride ion)
Crest Pro-health Paste, Dentifrice
FDA Label NDC 84126-624
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 84126-624). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, 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
Warnings
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.
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
glycerin, sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium citrate, flavor, sodium gluconate, carrageenan, xanthan gum, sodium saccharin, cocamidopropyl betaine, sodium hydroxide, stannous chloride, sucralose, titanium dioxide
Questions?
1-800-594-4158
Other
DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202
Principal Display Panel - 116 G Tube In Carton
Crest
Pro-Health
NET WT
5.1 OZ (144 g)
FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH
CAVITIES
GINGIVITIS
ENAMEL
PLAQUE
WHITENING
FRESHENS
BREATH
ADVANCED
MAX CAVITY
+ EROSION PREVENTION
DENTIST DESIGNED
CLINICALLY PROVEN
HELPS STOP CAVITIES
BEFORE THEY START
24h
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