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Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 U.S.A.
Colgate Optic White Platinum Stain Prevention Paste, Dentifrice
FDA Label NDC 35000-074
8 label sections · Submitted to the FDA by Colgate-palmolive Company · 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 Optic White Platinum Stain Prevention (NDC 35000-074). 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, directions, inactive ingredients, questions?, principal display panel - 116 g tube carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Monofluorophosphate 0.76% (0.12% w/v fluoride ion)
Purpose
Anticavity
Use
helps protect against cavities
Directions
| adults and children 6 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 6 to 12 years | use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) |
| children under 6 years | ask a dentist or physician |
Inactive Ingredients
Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, Silica, Water, Hydrogen Peroxide (3.5% w/v), Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Disodium Pyrophosphate, Sodium Saccharin, Sucralose, BHT.
Questions?
1-800-468-6502
Principal Display Panel - 116 G Tube Carton
Colgate®
Anticavity Fluoride Toothpaste
OPTIC
WHITE®
PLATINUM
DISSOLVES
10 YEARS
OF DEEP-SET STAINS*
3.5%
HYDROGEN
PEROXIDE
STAIN PREVENTION
PASTE
SPARKLING MINT
ENAMEL SAFE
NET WT 4.1 OZ (116 g)
Principal Display Panel (116 g Tube Carton)
* Please review the disclaimer below.
