Country: United States
Language: English
Source: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Medline Industries, LP
SODIUM FLUORIDE
SODIUM FLUORIDE 2.4 mg in 1 g
DENTAL
OTC DRUG
Anticavity toothpaste aids in the prevention of dental cavities
OTC monograph final
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._ ---------- 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 Read the complete document