COLGATE KIDS SPACE JAM  MILD BUBBLE FRUIT FLAVOR- sodium fluoride gel, dentifrice 
Colgate-Palmolive Company

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.

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Colgate® Kids Space Jam
Mild Bubble Fruit® Flavor

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE CO.
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

Colgate®
Anticavity
Fluoride Toothpaste

cavity
protection

Bubble Fruit®

SPACE
JAM
A NEW LEGACY

ADA
Accepted
American
Dental
Association®

Recyclable
Tube

NET WT 4.6 OZ (130 g)

PRINCIPAL DISPLAY PANEL - 130 g Tube Label
COLGATE KIDS SPACE JAM   MILD BUBBLE FRUIT FLAVOR
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-996
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R) 476 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-996-46130 g in 1 TUBE; Type 0: Not a Combination Product05/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35505/28/2021
Labeler - Colgate-Palmolive Company (001344381)

Revised: 5/2021
Document Id: 69fd4e30-23f8-4a1e-b806-07be972c9375
Set id: 4852983a-f582-4525-8a46-65d01d4cc777
Version: 1
Effective Time: 20210526
 
Colgate-Palmolive Company