COLGATE KIDS CAVITY PROTECTION- sodium fluoride gel, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Label - Pokémon

Colgate®
Anticavity Fluoride Toothpaste

cavity
protection

Bubble Fruit®

ADA
Accepted
American
Dental
Association®

Pokémon™

NET WT 4.6 OZ (130 g)

PRINCIPAL DISPLAY PANEL - 130 g Tube Label - Bluey

Colgate®
Anticavity Fluoride Toothpaste

cavity
protection

Bubble Fruit®

Bluey

Recyclable
Tube

ADA
Accepted
American
Dental
Association®

NET WT 4.6 OZ (130 g)

PRINCIPAL DISPLAY PANEL - 130 g Tube Label - Minecraft

Colgate®
Anticavity Fluoride Toothpaste

cavity
protection

Bubble Fruit®

MINECRAFT

Recyclable
Tube

ADA
Accepted
American
Dental
Association®

NET WT 4.6 OZ (130 g)

PRINCIPAL DISPLAY PANEL - 130 g Tube Label - Unicorn Academy

Colgate®
Anticavity Fluoride Toothpaste

cavity
protection

Bubble Fruit®

Unicorn
Academy

NETFLIX

ADA
Accepted
American
Dental
Association®

Recyclable
Tube

NET WT 4.6 OZ (130 g)

PRINCIPAL DISPLAY PANEL - 90 g Tube Label - Unicorn

Colgate®
Anticavity Fluoride Toothpaste

cavity
protection

Bubble Fruit®

unicorn

NET WT 3.2 OZ (90 g)

ADA
Accepted
American
Dental
Association®

PRINCIPAL DISPLAY PANEL - 90 g Tube Label - Dinosaur

Colgate®
Anticavity Fluoride Toothpaste

cavity
protection

Bubble Fruit®

dinosaur

NET WT 3.2 OZ (90 g)

ADA
Accepted
American
Dental
Association®

PRINCIPAL DISPLAY PANEL - 90 g Tube Label - Ocean Explorer

Colgate®
Anticavity Fluoride Toothpaste

cavity
protection

Bubble Fruit®

ocean explorer

NET WT 3.2 OZ (90 g)

ADA
Accepted
American
Dental
Association®

INGREDIENTS AND APPEARANCE

COLGATE KIDS CAVITY PROTECTION 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-015
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)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-015-46	130 g in 1 TUBE; Type 0: Not a Combination Product	05/05/2020
2	NDC: 35000-015-32	90 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	11/11/2016

Labeler - Colgate-Palmolive Company (001344381)

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

Establishment
Name	Address	ID/FEI	Business Operations
Mission Hills, S.A. de C.V.		812312122	ANALYSIS(35000-015) , MANUFACTURE(35000-015) , PACK(35000-015) , LABEL(35000-015)