Just For Kids

Just For Kids
SPL v6
SPL
SPL Set ID 0f1afc36-f699-4072-b90b-c9f5be989a49
Route
ORAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.969 mg)
Inactive Ingredients
Ascorbic Acid Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Anhydrous Citric Acid Glycerin Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1997-07-01

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Aids in the prevention of dental decay

Section 42229-5

Drug Facts

Section 50565-1
  • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
  • Keep out of reach of children. If more than used for brushing is accidentally swallowed, gel medical help or contact a Poison Control Center right away.
  • This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Warnings

Directions
  • Adults and children 6 years of age and older: Use a pea-sized (.25g) dose once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.
Other Information
  • Do not freeze or expose to extreme heat.
  • Do not use if tamper evident seal on top of box is broken or removed.
Inactive Ingredients

ascorbic acid, carbomer, citric acid, flavor, glycerin, triethanolamine

active Ingredient

Stannous fluoride 0.4% w/w (0.12% w/f fluoride ion)

Questions Or Comments?

call toll free M-F 9am to 5pm EST/EDT at 1-800-634-2249

Principle Display Panel Grape

Grapey Grape

NDC 48878-4020-3

3M ESPE

Just For Kids™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

directions thoroughly.

Contents:

NET WT. 4.3 oz (121.9 g)

Principle Display Panel Bubble Gum

Bubble Gum

NDC 48878-4070-3

3M ESPE

Just For Kids™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

directions thoroughly.

Contents:

NET WT. 4.3 oz (121.9 g)


Structured Label Content

Use

Aids in the prevention of dental decay

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
  • Keep out of reach of children. If more than used for brushing is accidentally swallowed, gel medical help or contact a Poison Control Center right away.
  • This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Purpose

Anticavity

Warnings

Directions
  • Adults and children 6 years of age and older: Use a pea-sized (.25g) dose once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.
Other Information (Other information)
  • Do not freeze or expose to extreme heat.
  • Do not use if tamper evident seal on top of box is broken or removed.
Inactive Ingredients (Inactive ingredients)

ascorbic acid, carbomer, citric acid, flavor, glycerin, triethanolamine

active Ingredient (Active ingredient)

Stannous fluoride 0.4% w/w (0.12% w/f fluoride ion)

Questions Or Comments? (Questions or comments?)

call toll free M-F 9am to 5pm EST/EDT at 1-800-634-2249

Principle Display Panel Grape (Principle Display Panel - Grape)

Grapey Grape

NDC 48878-4020-3

3M ESPE

Just For Kids™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

directions thoroughly.

Contents:

NET WT. 4.3 oz (121.9 g)

Principle Display Panel Bubble Gum (Principle Display Panel - Bubble Gum)

Bubble Gum

NDC 48878-4070-3

3M ESPE

Just For Kids™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

directions thoroughly.

Contents:

NET WT. 4.3 oz (121.9 g)


Advanced Ingredient Data


Raw Label Data

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