SPARKLE FRESH ANTICAVITY- sodium fluoride paste, dentifrice

Summary of Product characteristics

                                SPARKLE FRESH ANTICAVITY- SODIUM FLUORIDE PASTE, DENTIFRICE
MEDLINE INDUSTRIES, LP
_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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082 SPARKLFRESH FLOURIDE TOOTHPASTE
_ACTIVE INGREDIENT_
Sodium Fluoride (0.15% w/v of Fluoride Ion)
_PURPOSE_
Anticavity toothpaste
_USES_
aids in the prevention of dental cavities
_WARNINGS_
KEEP OUT OF REACH OF CHILDREN UNDER 6 YRS. OF AGE.
If you accidentally swallow more than used for brushing, seek medical
help or contact a
Poison Control Center immediately.
_DIRECTIONS_
Adults and children 2 yrs and older: brush teeth thoroughly after
meals or at least
twice a day or as directed by a dentist or physician.
Instruct children under 6 yrs. of age in good brushing and rinsing
habits (to minimize
swallowing)
Supervise children as necessary until capable of using without
supervision
Children under 2 yrs. of age: Consult a dentist or physician
_INACTIVE INGREDIENTS_
Cellulose Gum, Disodium Phosphate, FD&C Blue No. 1, Flavor, Glycerin,
Hydrated Silica,
PEG 6, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Titanium
Dioxide, Water.
MANUFACTURING INFORMATION
Manufactured for: Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA
www.medline.com
1-800-MEDLINE
REF: NONTP85DS
RA17SFZ
PACKAGE LABEL
SPARKLE FRESH ANTICAVITY
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:53329-082
Medline Industries, LP
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
SODIUM FLUORIDE
2.4 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T
                                
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