OTC Medication Information: Colgate Optic White Renewal Enamel Strength

COLGATE OPTIC WHITE RENEWAL ENAMEL STRENGTH- sodium monofluorophosphate paste, dentifrice
Colgate-Palmolive Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Sodium Monofluorophosphate 1.14% (0.18% 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 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, PVP, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Silica, Sucralose, BHT.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL — 85 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

NEW

OPTIC
WHITE®

RENEWAL

REMOVES
10 YEARS OF
YELLOW STAINS*

HYDROGEN
3%
PEROXIDE

ENAMEL STRENGTH

NET WT 3.0 OZ (85 g)

ENAMEL SAFE

PRINCIPAL DISPLAY PANEL -- 85 g Tube Carton
(click image for full-size original)
COLGATE OPTIC WHITE RENEWAL ENAMEL STRENGTH
sodium monofluorophosphate paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-980
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL 527.8 mg in 1 g
CALCIUM PYROPHOSPHATE
POVIDONE K15
PEG/PPG-116/66 COPOLYMER
HYDROGEN PEROXIDE
SODIUM LAURYL SULFATE
SODIUM PYROPHOSPHATE
SACCHARIN SODIUM
SODIUM ACID PYROPHOSPHATE
SILICON DIOXIDE
SUCRALOSE
BUTYLATED HYDROXYTOLUENE
Product Characteristics
Color WHITE Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35000-980-63 1 TUBE in 1 CARTON contains a TUBE
1 85 g in 1 TUBE This package is contained within the CARTON (35000-980-63)
2 NDC:35000-980-60 2 TUBE in 1 CARTON contains a TUBE
2 85 g in 1 TUBE This package is contained within the CARTON (35000-980-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 11/04/2019
Labeler — Colgate-Palmolive Company (001344381)

Revised: 10/2019 Colgate-Palmolive Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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