Colgate® Junior Dora Fluoride Toothpaste

Colgate by

Drug Labeling and Warnings

Colgate 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  JUNIOR DORA- sodium fluoride paste, 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® Junior Dora 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, hydrated silica, PEG-12, cellulose gum, sodium layryl sulfate, flavor, sodium saccharin, mica, titanium dioxide, FD&C red no. 40, D&C red no. 33

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130g Tube Label

Colgate®
Fluoride Toothpaste

CLINICALLY PROVEN
Cavity & Enamel Protection

ADA
Accepted
American
Dental
Association ®

Toothpaste

nickelodeon™
DORA
the
EXPLORER™

NET WT
4.6 OZ
(130g)

Mild BUBBLE FRUIT®

COLGATE   JUNIOR DORA
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-534
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)	476 mg  in 1 g
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)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-534-46	130 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/01/2011	05/31/2019

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

Revised: 4/2019

Document Id: d4269fbf-764b-42e4-9c2f-280b43e1e3d6

34390-5

Set id: b2ca5eb7-b014-4f48-8280-09429426fbc8

Version: 4

Effective Time: 20190408