COLGATE® KIDS GEL TOOTHPASTE - BUBBLEFRUIT

COLGATE KIDS - BUBBLEFRUIT by

Drug Labeling and Warnings

COLGATE KIDS - BUBBLEFRUIT by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE KIDS - BUBBLEFRUIT- sodium fluoride gel, dentifrice 
Mission Hills S.A de C.V

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 GEL TOOTHPASTE - BUBBLEFRUIT

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, Titanium Dioxide.

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

Clinically Proven
Cavity & Enamel Protection

pocket.watch

RYAN'S
WORLD™

ADA
Accepted
American
Dental
Association ®

Toothpaste

NET WT
4.6 OZ
(130 g)

RYAN'S BUBBLE FRUIT®

PRINCIPAL DISPLAY PANEL - 130 g Tube Label
COLGATE KIDS - BUBBLEFRUIT 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65954-594
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)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-594-46130 g in 1 TUBE; Type 0: Not a Combination Product04/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/12/2019
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 12/2019
 
Mission Hills S.A de C.V