Colgate Kids Maximum Cavity Protection Batman: Package Insert and Label Information

COLGATE KIDS MAXIMUM CAVITY PROTECTION BATMAN- sodium fluoride gel, dentifrice
Colgate-Palmolive

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.

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, Blue 1, Yellow 10.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL — 124 g Tube Label

Colgate^®
Anticavity Fluoride Toothpaste

Maximum
Cavity Protection*

Mild BUBBLE FRUIT^®

LESS
MESS

ADA
Accepted
American
Dental
Association^®

NET WT
4.4 OZ (124 g)

COLGATE KIDS MAXIMUM CAVITY PROTECTION BATMAN sodium fluoride gel, dentifrice

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-191 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg in 1 g

Inactive Ingredients Ingredient Name Strength SORBITOL WATER HYDRATED SILICA POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM LAURYL SULFATE SACCHARIN SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 1

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:35000-191-44 124 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 02/22/2021

Labeler — Colgate-Palmolive (001344381)

Establishment
Name	Address	ID/FEI	Operations
Accupac		061595175	MANUFACTURE (35000-191)

Revised: 02/2021 Colgate-Palmolive