SPARKLE FRESH ANTICAVITY

Main information

  • Trade name:
  • SPARKLE FRESH ANTICAVITY- sodium fluoride paste, dentifrice
  • Composition:
  • SODIUM FLUORIDE 2.4 mg in 1 g
  • Administration route:
  • DENTAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SPARKLE FRESH ANTICAVITY- sodium fluoride paste, dentifrice
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Anticavity toothpaste aids in the prevention of dental cavities

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 53329-082-21, 53329-082-92, 53329-082-93, 53329-082-94
  • Last update:
  • 29-05-2019

Summary of Product characteristics: dosage, interactions, side effects

SPARKLE FRESH ANTICAVITY- sodium fluoride paste, dentifrice

Medline Industries, Inc.

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.

----------

Drug Facts

Active ingredient

Sodium Fluoride (0.15% w/v of Fluoride Ion)

Purpos e

Anticavity toothpaste

Us es

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

Medline

Fluoride Toothpaste

REF NONTP85DS

Net Wt 0.85 oz (24 g)

SPARKLE FRESH ANTICAVITY

sodium fluoride paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53329 -0 8 2

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Medline Industries, Inc.

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

SODIUM FLUORIDE

2.4 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

SO DIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: 9 4255I6 E2T)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

PO LYETHYLENE GLYCO L 3 0 0 (UNII: 56 55G9 Y8 AQ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO RBITO L (UNII: 50 6 T6 0 A25R)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:53329 -0 8 2-9 3

24 g in 1 TUBE

2

NDC:53329 -0 8 2-9 4

78 g in 1 TUBE

3

NDC:53329 -0 8 2-21

42.5 g in 1 TUBE

4

NDC:53329 -0 8 2-9 2

17 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 4/0 1/20 0 8

Labeler -

Medline Industries, Inc. (025460908)

Revised: 5/2010