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Drug Facts
Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 U.S.A.
Colgate Optic White Pro Series Hi White Paste, Dentifrice
FDA Label NDC 35000-792
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 Optic White Pro Series Hi White (NDC 35000-792). 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 Monofluorophosphate 1.14% (0.18% 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 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 | do not use unless directed by a dentist or physician |
Inactive Ingredients
Propylene Glycol, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Water, Hydrogen Peroxide (5% w/v), PVP, Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.
Questions?
1-800-468-6502
Principal Display Panel - 85 G Tube Carton
Colgate®
Anticavity Fluoride Toothpaste
OPTIC
WHITE®
PRO SERIES
REMOVES
15 YEARS
OF DEEP-SET STAINS*
ACTIV-SHINE
TECHNOLOGY
5%
HYDROGEN
PEROXIDE
HIGH IMPACT WHITE
PASTE BRILLIANT MINT
ENAMEL SAFE
NET WT 3.0 OZ (85 g)
Principal Display Panel (85 g Tube Carton)
* Please review the disclaimer below.
