Drug labels

Colgate Kids Cavity Protection

SODIUM FLUORIDE · Colgate-Palmolive Company · DENTAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
f0e68196-8566-443b-9cc8-b57d5c001558
ID
d203ad42-ee3f-42fa-9213-6cf6026117ca
Effective time
20261019
Version
4
SPL product data elements

Colgate Kids Cavity Protection Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM LAURYL SULFATE SACCHARIN SODIUM FD&C BLUE NO. 1 D&C YELLOW NO. 10

SPL unclassified section
Drug Facts, Dist. by: COLGATE-PALMOLIVE CO. New York, NY 10022 U.S.A.
Active ingredient
Active ingredient Sodium Fluoride 0.24% (0.15% w/v fluoride ion)
Purpose
Purpose Anticavity
Indications and usage
Use helps protect against cavities
Warnings

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.

Keep out of reach of children

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.

Dosage and administration

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

Dosage and administration table

<table width="60%" styleCode="Noautorules"><col width="30%" align="left" valign="top"/><col width="70%" align="left" valign="top"/><tbody><tr styleCode="Botrule"><td styleCode="Rrule">adults and children 2 years of age and older</td><td>brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">children 2 to 6 years</td><td>use only a pea sized amount and supervise child&apos;s brushing and rinsing (to minimize swallowing)</td></tr><tr><td styleCode="Rrule">children under 2 years</td><td>ask a dentist or physician</td></tr></tbody></table>

Inactive ingredient
Inactive ingredients Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.
Questions
Questions? 1-800-468-6502
Package label principal display panel

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 - Pokémon

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 - Bluey

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 - Minecraft

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 - 130 g Tube Label - Unicorn Academy

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 - Unicorn

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 - Dinosaur

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 ® PRINCIPAL DISPLAY PANEL - 90 g Tube Label - Ocean Explorer

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton Colgate ® Fluoride Toothpaste KIDS cavity protection fights cavities strengthens teeth gentle on tooth enamel ADA Accepted American Dental Association ® Bubble Fruit ® NET WT 4.6 OZ (130 g) PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

PRINCIPAL DISPLAY PANEL - 24 g Tube Carton Colgate ® Fluoride Toothpaste KIDS cavity protection fights cavities strengthens teeth gentle on tooth enamel ADA Accepted American Dental Association ® Bubble Fruit ® NET WT 0.85 OZ (24 g) PRINCIPAL DISPLAY PANEL - 24 g Tube Carton

PRINCIPAL DISPLAY PANEL - 76 g Tube Carton Colgate ® Fluoride Toothpaste KIDS cavity protection fights cavities strengthens teeth gentle on tooth enamel ADA Accepted American Dental Association ® Bubble Fruit ® NET WT 2.7 OZ (76 g) PRINCIPAL DISPLAY PANEL - 76 g Tube Carton

PRINCIPAL DISPLAY PANEL - 2x 130 g Tube Carton Colgate ® Fluoride Toothpaste 2 VALUE PACK KIDS cavity protection sugar free no artificial preservatives paraben free Bubble Fruit ® ADA Accepted American Dental Association ® TWO 4.6 OZ (130 g) TUBES TOTAL NET WT 9.2 OZ (260 g) PRINCIPAL DISPLAY PANEL - 2x 130 g Tube Carton

Harmonized identifiers (openFDA)
Application number
M021
Brand name
Colgate Kids Cavity Protection
Generic name
SODIUM FLUORIDE
Manufacturer name
Colgate-Palmolive Company
Product NDC
35000-015
Product type
HUMAN OTC DRUG
Route
DENTAL
Substance name
SODIUM FLUORIDE
RxCUI
416783
SPL ID
d203ad42-ee3f-42fa-9213-6cf6026117ca
SPL set ID
f0e68196-8566-443b-9cc8-b57d5c001558
Package NDC
35000-015-46, 35000-015-32, 35000-015-47, 35000-015-20, 35000-015-59, 35000-015-45, 35000-015-24
Is original packager
true
Upc
0827854032571, 0827854032588
UNII
8ZYQ1474W7
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