JUST FOR KIDS- stannous fluoride gel 
Solventum US OpCo LLC

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Just For Kids

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental decay

Warnings

  • 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.

Directions

Other information

Inactive ingredients

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

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)

Principal Display Panel - Grape

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)

Principal Display Panel - Bubble Gum

JUST FOR KIDS 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-4020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.969 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Glycerin (UNII: PDC6A3C0OX)  
Trolamine (UNII: 9O3K93S3TK)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48878-4020-31 in 1 BOX07/01/1997
1121.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/01/1997
JUST FOR KIDS 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-4070
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.969 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Glycerin (UNII: PDC6A3C0OX)  
Trolamine (UNII: 9O3K93S3TK)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (BUBBLE GUM) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48878-4070-31 in 1 BOX07/01/1997
1121.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/01/1997
Labeler - Solventum US OpCo LLC (801390852)
Establishment
NameAddressID/FEIBusiness Operations
Dental Technologies, Inc.148312838MANUFACTURE(48878-4020, 48878-4070)

Revised: 4/2024
Document Id: 6d513acf-c26a-449f-a704-76c80d61feb2
Set id: 0f1afc36-f699-4072-b90b-c9f5be989a49
Version: 5
Effective Time: 20240401
 
Solventum US OpCo LLC