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

Package Label

SPARKLE FRESH ANTICAVITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-082
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-082-9324 g in 1 TUBE; Type 0: Not a Combination Product04/01/200808/31/2022
2NDC:53329-082-9478 g in 1 TUBE; Type 0: Not a Combination Product04/01/200808/31/2022
3NDC:53329-082-2142.5 g in 1 TUBE; Type 0: Not a Combination Product04/01/200808/31/2022
4NDC:53329-082-9217 g in 1 TUBE; Type 0: Not a Combination Product04/01/200801/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/200808/31/2022
Labeler - Medline Industries, LP (025460908)

Revised: 10/2021
 
Medline Industries, LP