OTC Medication Information: Colgate Optic White Stain Fighter Clean Mint

COLGATE OPTIC WHITE STAIN FIGHTER CLEAN MINT- sodium fluoride 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 Fluoride 0.24% (0.15% 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 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

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Sodium Saccharin, Benzyl Alcohol, Titanium Dioxide.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL — 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®

STAIN FIGHTER®

REMOVES 5X MORE SUFACE STAINS*
WITH MICRO-POLISHING ACTION

ENAMEL SAFE
NET WT 6.0 OZ (170 g)

CLEAN MINT PASTE

PRINCIPAL DISPLAY PANEL -- 170 g Tube Carton
(click image for full-size original)
COLGATE OPTIC WHITE STAIN FIGHTER CLEAN MINT
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-261
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER 191.18 mg in 1 g
SORBITOL
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
POTASSIUM PYROPHOSPHATE
PHOSPHORIC ACID
COCAMIDOPROPYL BETAINE
SACCHARIN SODIUM
BENZYL ALCOHOL
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35000-261-71 1 TUBE in 1 CARTON contains a TUBE
1 119 g in 1 TUBE This package is contained within the CARTON (35000-261-71)
2 NDC:35000-261-02 1 TUBE in 1 CARTON contains a TUBE
2 56.6 g in 1 TUBE This package is contained within the CARTON (35000-261-02)
3 NDC:35000-261-60 1 TUBE in 1 CARTON contains a TUBE
3 170 g in 1 TUBE This package is contained within the CARTON (35000-261-60)
4 NDC:35000-261-33 1 TUBE in 1 CARTON contains a TUBE
4 36.8 g in 1 TUBE This package is contained within the CARTON (35000-261-33)
5 NDC:35000-261-30 1 TUBE in 1 CARTON contains a TUBE
5 85 g in 1 TUBE This package is contained within the CARTON (35000-261-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 06/01/2022
Labeler — Colgate-Palmolive Company (001344381)

Revised: 06/2022 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.

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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