COLGATE OPTIC WHITE RELIEF- sodium fluoride paste, dentifrice

COLGATE OPTIC WHITE RELIEF by

Drug Labeling and Warnings

COLGATE OPTIC WHITE RELIEF by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Potassium Nitrate 5%	Antisensitivity
Sodium Fluoride 0.24% (0.15% w/v fluoride ion)	Anticavity

Uses

• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
• helps protect against cavities

Warnings

When using this product, if pain/sensitivity persists after 4 weeks, visit your dentist.

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
• children under 12 years: consult 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, Benzyl Alcohol, Sodium Saccharin, Titanium Dioxide.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 107 g Tube Carton

Colgate®
Anticavity Toothpaste for Sensitive Teeth

OPTIC
WHITE®
SENSITIVITY
RELIEF

PASTE SOOTHING MINT

REMOVES 1 YEAR
OF STAINS*
WITH MICRO-POLISHING ACTION

NET WT 3.8 OZ (107 g)

ENAMEL SAFE

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE RELIEF 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-834
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	1777.69 mg  in 1 g
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
PHOSPHORIC ACID (UNII: E4GA8884NN)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-834-59	1 in 1 CARTON	09/25/2025
1		107 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	09/25/2025

Labeler - Mission Hills S.A de C.V (812312122)