POTASSIUM HYDROXIDE- potassium hydroxide liquid

POTASSIUM HYDROXIDE by

Drug Labeling and Warnings

POTASSIUM HYDROXIDE by is a Prescription medication manufactured, distributed, or labeled by Gordon Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Clear liquid solution containing Potassium Hydroxide Solution 5%.

HOW SUPPLIED

Potassium Hydroxide Solution 5% supplied as 2oz. Amber Glass Bottle.

SPL UNCLASSIFIED SECTION

Potassium Hydroxide Solution 5%, Purified water (usp)

INDICATIONS & USAGE

Used as a softener for nail grooves. Also used as a slide medium in Potassium Hydroxide preparations. Apply to nail in office.

WARNINGS AND PRECAUTIONS

May cause skin irritation. Do not get in eyes, on skin, or on clothing. In case of contact, immediately flush skin or eyes with plenty of water for at least 15 minutes. For eyes, contact a Physician. For external use only. Keep out of reach of children. For Physician use only. Poison: Harmful if taken internally.

SPL UNCLASSIFIED SECTION

For Physician use only. Store at room temperature 59o-86oF (15o - 30o C)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POTASSIUM HYDROXIDE  
potassium hydroxide liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10481-3012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) (POTASSIUM HYDROXIDE - UNII:WZH3C48M4T)	POTASSIUM HYDROXIDE	.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10481-3012-1	59 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/16/2010

Labeler - Gordon Laboratories (002333847)

Registrant - Gordon Laboratories (002333847)

Establishment
Name	Address	ID/FEI	Business Operations
Gordon Laboratories		002333847	manufacture