CREST PRO-HEALTH STAGES- 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 Manufacturing 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 PRO-HEALTH STAGES- 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._
----------
CREST PRO-HEALTH STAGES
_DRUG FACTS_
ACTIVE INGREDIENT
Sodium fluoride 0.243% (0.15% w/v fluoride ion)
PURPOS E
Anticavity toothpaste
US E
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
twist off cap to remove foil seal
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, cellulose gum, flavor,
sodium phosphate, sodium saccharin, carbomer, blue 1
QUES TIONS ?
1-800-285-9139
Dist. by Procter & Gamble,
Cincinnati, OH 45202
PRINCIPAL DISPLAY PANEL - 120 G TUBE LABEL
®
®
®
2+
YEARS
BERRY
DISNEY
JAKE
AND
THE
NEVER LAND
PIRATES
ANTICAVITY FLUORIDE TOOTHPASTE
_CREST_
PRO-HEALTH
STAGES
NET WT 4.2 OZ (120 G)
®
®
®
CREST PRO-HEALTH STAGES
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:370 0 0 -6 75
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40
8 O)
FLUORIDE ION
1.5 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO RBITO L (UNII: 50 6 T6 0 A25R)
WATER (UNII: 0 59 QF0 KO0 R)
HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
SO DIUM PHO SPHATE, TRIBASIC, M