Sparkle fresh anticavity paste, dentifrice

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.

Ingredients and appearance - Product information

Sparkle fresh anticavity paste, dentifrice- Sodium fluoride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 53329-082
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 2.4 mgin 1 g

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 53329-082-93 24g in 1 TUBE 2008/04/01
2 NDC: 53329-082-94 78g in 1 TUBE 2008/04/01
3 NDC: 53329-082-21 42.5g in 1 TUBE 2008/04/01
4 NDC: 53329-082-92 17g in 1 TUBE 2008/04/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part355 USA 2008/04/01

Labeler - Medline Industries, Inc.( 025460908)

Establishment

Name ID/FEI Business Operations
Medline Industries, Inc. 025460908 manufacture( 53329-082)

Package/label principal display panel

SparkleFresh

Medline

Fluoride Toothpaste

REF NONTP85DS

Net Wt 0.85 oz (24 g)