GLOW in the DARK Colgate® Fluoride Toothpaste

Colgate Kids by

Drug Labeling and Warnings

Colgate Kids 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  HALLOWEEN WICKED WATERMELON- 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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GLOW in the DARK
Colgate®
Fluoride Toothpaste

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 older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
• children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask a dentist or physician

Inactive ingredients

sorbitol, water, glycerin, hydrated silica, PEG-12, sodium lauryl sulfate, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, flavor, xanthan gum, FD&C blue no. 1, FD&C yellow no. 5

Questions?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

GLOW in the DARK

Colgate®

Clinically Proven Cavity and Enamel Protection

Fluoride Toothpaste

wicked
watermelon
flavor

NET WT 4.6 OZ (130 g) LIQUID GEL

COLGATE KIDS   HALLOWEEN WICKED WATERMELON
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-504
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)	646.15 mg  in 1 g
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	WATERMELON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-504-81	130 g in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	07/26/2011

Labeler - Mission Hills S.A. de C.V. (812312122)

Revised: 4/2019

Document Id: f8c788a3-fc47-4501-971f-fc3484598d8f

34390-5

Set id: 8f1b4446-721e-461a-af6b-0cccace85ce2

Version: 3

Effective Time: 20190408

 

Mission Hills S.A. de C.V.