CREST 3D WHITE WHITENING THERAPY GENTLE CARE COCONUT OIL- sodium fluoride paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Procter & Gamble Manfuacturing Company

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anticavity toothpaste helps protect against cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

CREST 3D WHITE WHITENING THERAPY GENTLE CARE COCONUT OIL- SODIUM
FLUORIDE PASTE, DENTIFRICE
PROCTER & GAMBLE MANFUACTURING COMPANY
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
CREST®
3D WHITE™
WHITENING THERAPY
GENTLE CARE
COCONUT OIL
_DRUG FACTS_
ACTIVE INGREDIENT
Sodium fluoride 0.243% (0.15% w/v fluoride ion)
PURPOSE
Anticavity toothpaste
USE
helps protect against cavities
WARNINGS
KEEP OUT OF REACH OF CHILDREN UNDER 6 YRS. OF AGE. If more than used
for brushing
is accidentally swallowed, get medical help or contact a Poison
Control Center right
away.
DIRECTIONS
adults and children 2 yrs. & older: brush teeth thoroughly after meals
or at least
twice a day or use as directed by a dentist
do not swallow
to minimize swallowing use a pea-sized amount in children under 6
supervise children's brushing until good habits are established
children under 2 yrs.: ask a dentist
INACTIVE INGREDIENTS
water, sorbitol, hydrated silica, disodium pyrophosphate, sodium
lauryl sulfate, flavor,
cellulose gum, sodium hydroxide, sodium saccharin, carbomer, cocos
nucifera
(coconut) oil, sucralose, polysorbate 80, titanium dioxide
QUESTIONS?
1-800-492-7378
DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202
PRINCIPAL DISPLAY PANEL - 116 G CARTON
_CREST_®
3D WHITE™
FLUORIDE ANTICAVITY TOOTHPASTE
WHITENING
THERAPY™
_coconut_
_oil_
GENTLE CARE
SMOOTH MINT
NET WT 4.1 OZ (116 g)
CREST 3D WHITE WHITENING THERAPY GENTLE CARE COCONUT
OIL
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:37000-214
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
FLUORIDE ION
1.5 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
CARBOXYMETHYLCELLULOSE SODIUM