SPL v7
SPL
SPL Set ID 786c6184-6bc8-4376-9ce2-3e35af193210
Route
ORAL
Published
Effective Date 2020-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.950 mg)
Inactive Ingredients
Water Sorbitol Silicon Dioxide Glycerin Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate Titanium Dioxide Carboxymethylcellulose Sodium Saccharin Sodium Tricalcium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-07-18

Description

Drug Facts

Purpose

Anticavity Toothpaste


Medication Information

Purpose

Anticavity Toothpaste

Description

Drug Facts

Use

helps protect teeth and roots against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing, use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 years, ask your dentist
Active Ingredient

Sodium fluoride 0.21% (0.12% w/v fluoride ion)

Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, polyethylene-polypropylene glycol, flavor, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, carboxymethyl cellulose, sodium saccharin, tri-calcium phoshate

Principal Display Panel

NDC 48878-3150-4

3M ESPE

Clinpro™ Tooth Crème

Vanilla Mint

0.21% Sodium Flouride

Anti-Cavity Toothpaste

Contents: 1 Tube NET WT 4 oz (113 g)


Structured Label Content

Use

helps protect teeth and roots against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity Toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing, use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 years, ask your dentist
Active Ingredient (Active ingredient)

Sodium fluoride 0.21% (0.12% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, glycerin, polyethylene-polypropylene glycol, flavor, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, carboxymethyl cellulose, sodium saccharin, tri-calcium phoshate

Principal Display Panel

NDC 48878-3150-4

3M ESPE

Clinpro™ Tooth Crème

Vanilla Mint

0.21% Sodium Flouride

Anti-Cavity Toothpaste

Contents: 1 Tube NET WT 4 oz (113 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)