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

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