FDA.reportPublic FDA data

POTASSIUM HYDROXIDE

Manufacturer
Gordon Laboratories
Effective date
2010-07-16
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-02 01:50:59

Label at a glance#

ProductPOTASSIUM HYDROXIDE
Active ingredientPOTASSIUM HYDROXIDE
Label structure7 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Clear liquid solution containing Potassium Hydroxide Solution 5%.

HOW SUPPLIED SECTION

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

SPL UNCLASSIFIED SECTION


Potassium Hydroxide Solution 5%, Purified water (usp)

INDICATIONS & USAGE SECTION

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 SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Potassium Hydroxide SolutionImage of Potassium Hydroxide Solution

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10481-3012-12021-11-06C16284748780-1960f7f55-c2e1-8e05-e053-dbdaa90a074aPOTASSIUM HYDROXIDE
10481-3012-12019-10-29C16284748780-1960f7f55-c2e1-8e05-e053-dbdaa90a074aPOTASSIUM HYDROXIDE

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10481-3012-1ML - Milliliter10481-3012b4075dc1-c005-4d31-84e1-e512fee709e212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM HYDROXIDEACTIVE INGREDIENTWZH3C48M4T10
POTASSIUM HYDROXIDEACTIVE MOIETYWZH3C48M4T10
WATERINACTIVE INGREDIENT059QF0KO0R10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10481-301210481-3012-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM HYDROXIDEWZH3C48M4TACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cfe5b514-921c-08a8-e053-2995a90a49ba6eeb7bf1-cfd6-4574-94bb-ff69ec91359f2021-11-03WarningsExact identifier
spl set id: 6eeb7bf1-cfd6-4574-94bb-ff69ec91359f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.