CREST BLUE BUBBLE GUM- sodium fluoride paste, dentifrice

Summary of Product characteristics

                                CREST BLUE BUBBLE GUM- SODIUM FLUORIDE PASTE, DENTIFRICE
PROCTER & GAMBLE MANUFACTURING 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._
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CREST
BLUE BUBBLE GUM
_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
sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium
phosphate, flavor,
sodium phosphate, cellulose gum, carbomer, sodium saccharin, blue 1
_QUESTIONS?_
1-800-492-7378
®
Dist. by Procter & Gamble,
Cincinnati, OH 45202
PRINCIPAL DISPLAY PANEL - 119 G PUMP LABEL
FIGHTS CAVITIES
_CREST_®
FLUORIDE ANTICAVITY TOOTHPASTE
BLUE BUBBLE GUM
_STAR_
_WARS™_
GENTLE ON ENAMEL
STRENGTHENS ENAMEL
NET WT 4.2 OZ (119 g)
CREST BLUE BUBBLE GUM
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:37000-495
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
Procter & Gamble Manufacturing Company
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0K
                                
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