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Drug Facts
Dist. by:
COLGATE-PALMOLIVE CO.
New York, NY 10022 U.S.A.
Colgate Junior Kids Batman Mild Bubble Fruit Fluoride Gel, Dentifrice
FDA Label NDC 35000-950
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Colgate-palmolive Company for the product Colgate Junior Kids Batman Mild Bubble Fruit Fluoride (NDC 35000-950). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.24% (0.15% w/v fluoride ion)
Purpose
Anticavity
Use
helps protect against cavities
Otc - 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.
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, D&C yellow no. 10, FD&C blue no. 1
Questions?
1-800-468-6502
Principal Display Panel - 130 G Tube Label
Colgate®
Anticavity Fluoride Toothpaste
CLINICALLY PROVEN
Cavity & Enamel Protection
ADA
ACCEPTED
American
Dental
Association ®
Toothpaste
NET WT
4.6 OZ
(130 g)
Mild BUBBLE FRUIT®
Principal Display Panel (130 g Tube Label)
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