SPARKLE FRESH ANTICAVITY- sodium fluoride paste, dentifrice

Sparkle Fresh Anticavity by

Drug Labeling and Warnings

Sparkle Fresh Anticavity by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Package/Label Principal Display Panel

SparkleFresh

Medline

Fluoride Toothpaste

REF NONTP85DS

Net Wt 0.85 oz (24 g)

INGREDIENTS AND APPEARANCE

SPARKLE FRESH ANTICAVITY 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-082
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: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-082-93	24 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2008
2	NDC: 53329-082-94	78 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2008
3	NDC: 53329-082-21	42.5 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2008
4	NDC: 53329-082-92	17 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/01/2008

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(53329-082)