083 Sparklefresh Fluoride Toothpaste

083 Sparklefresh Fluoride Toothpaste
SPL v7
SPL
SPL Set ID 1565528b-89f2-4c97-b294-15b6ebd3f80e
Route
DENTAL
Published
Effective Date 2022-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Water Methylparaben Sodium Silicate Saccharin Titanium Dioxide Polyethylene Glycol 400 Propylparaben Silicon Dioxide Carboxymethylcellulose Sodium Calcium Carbonate Sodium Lauryl Sulfate Sorbitol Sodium Pyrophosphate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-01

Description

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste


Medication Information

Purpose

Anticavity toothpaste

Description

Sodium Monofluorophosphate 0.76%

Use

aids in the prevention of dental cavities

Warnings

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 years of age in good brushing and rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 2 years of age: consult a dentist or physician

Package Label

Active Ingredient

Sodium Monofluorophosphate 0.76%

Inactive Ingredients

calcium carbonate, treated water, sorbitol, precipitated silica, sodium lauryl sulfate, flavor, sodium carboxymethyl cellulose, sodium silicate, tetrasodium pyrophosphate, sodium saccharin, methylparaben, titanium dioxide, polyethylene glycol 400, propylparaben

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.medline.com

1-800-MEDLINE (633-5463)

REF: NONTP15I

RH22NWI

Keep Out of Reach of Children Under 6 Years of Age.

If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Center immediately.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity toothpaste

Warnings

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 years of age in good brushing and rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 2 years of age: consult a dentist or physician

Package Label

Active Ingredient (Active ingredient)

Sodium Monofluorophosphate 0.76%

Inactive Ingredients (Inactive ingredients)

calcium carbonate, treated water, sorbitol, precipitated silica, sodium lauryl sulfate, flavor, sodium carboxymethyl cellulose, sodium silicate, tetrasodium pyrophosphate, sodium saccharin, methylparaben, titanium dioxide, polyethylene glycol 400, propylparaben

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.medline.com

1-800-MEDLINE (633-5463)

REF: NONTP15I

RH22NWI

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Center immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)