POTASSIUM HYDROXIDE- potassium hydroxide liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) (POTASSIUM HYDROXIDE - UNII:WZH3C48M4T)

Available from:

Gordon Laboratories

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

unapproved drug other

Summary of Product characteristics

POTASSIUM HYDROXIDE - POTASSIUM HYDROXIDE LIQUID
GORDON LABORATORIES
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
POTASSIUM HYDROXIDE
Clear liquid solution containing Potassium Hydroxide Solution 5%.
Potassium Hydroxide Solution 5% supplied as 2oz. Amber Glass Bottle.
Potassium Hydroxide Solution 5%, Purified water (usp)
Used as a softener for nail grooves. Also used as a slide medium in
Potassium Hydroxide preparations.
Apply to nail in office.
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.
For Physician use only. Store at room temperature 59 -86 F (15 - 30
C)
POTASSIUM HYDROXIDE
potassium hydroxide liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:10 48 1-30 12
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
o
o
o
o
Gordon Laboratories
PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T) (POTASSIUM HYDROXIDE -
UNII:WZH3C48 M4T)
POTASSIUM
HYDROXIDE
.0 5 g
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:10 48 1-30 12-1
59 g in 1 BOTTLE, GLASS
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 7/16 /20 10
LABELER -
Gordon Laboratories (002333847)
REGISTRANT -
Gordon Laboratories (002333847)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Go rdo n Labo rato ries
0 0 23338 47
ma nufa c ture
Revised: 7/2010