Your browser does not support JavaScript! SPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]
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RxNorm Names

SPARKLE FRESH ANTICAVITY (sodium fluoride) paste, dentifrice
[Medline Industries, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 Fluoride Toothpaste

SparkleFresh Fluoride Toothpaste

SparkleFresh

Medline

Fluoride Toothpaste

REF NONTP85DS

Net Wt 0.85 oz (24 g)

SPARKLE FRESH ANTICAVITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53329-082
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C BLUE NO. 1 
GLYCERIN 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 300 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
SORBITOL 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-082-9324 g in 1 TUBE
2NDC:53329-082-9478 g in 1 TUBE
3NDC:53329-082-2142.5 g in 1 TUBE
4NDC:53329-082-9217 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/2008
Labeler - Medline Industries, Inc. (025460908)

Revised: 5/2010
 
Medline Industries, Inc.

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