COLGATE FLUORIDE TOOTHPASTE-PEPPA PIG-MILD BUBBLE FRUIT- 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® Fluoride Toothpaste-Peppa Pig™-Mild Bubble Fruit®

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 lauryl 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 CO.
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

Colgate®
Anticavity Fluoride Toothpaste

CLINICALLY PROVEN
Cavity & Enamel Protection

Peppa Pig™

ADA
Accepted
American
Dental
Association ®

Toothpaste

NET WT
4.6 OZ
(130 g)

Mild BUBBLE FRUIT®

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

COLGATE FLUORIDE TOOTHPASTE-PEPPA PIG-MILD BUBBLE FRUIT
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-596
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
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)
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65954-596-46	130 g in 1 TUBE; Type 0: Not a Combination Product	07/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	07/10/2017	10/08/2021

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

Revised: 4/2019

Document Id: e9b317c2-3d5f-4764-82ad-b97c18244b60

Set id: 37baed91-b6b2-4c31-b8b6-6c46dd827737

Version: 4

Effective Time: 20190418

Mission Hills S.A de C.V