Osong Power gel

Manufacturer
Osong Co., Ltd.
Effective date
2020-12-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:53

Label at a glance#

ProductOsong Power gel
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

alcohol

OTC - PURPOSE SECTION

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic to decrease bacteria on the skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE SECTION

■ Pour a small amount into hands, spread evenly and rub into the skin

WARNINGS SECTION

For external use only

When using this product

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this on areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

DOSAGE & ADMINISTRATION SECTION

for external use only

INACTIVE INGREDIENT SECTION

Butylene Glycol, Concentrated Glycerin, Carbomer, Trolamine, and Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81294-0001-12022-01-28C16284748780-1d6a99b39-b5aa-a426-e053-dadaa90af4c2Drug Facts
81294-0001-22022-01-28C16284748780-1d6a99b39-b5aa-a426-e053-dadaa90af4c2Drug Facts
81294-0001-32022-01-28C16284748780-1d6a99b39-b5aa-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81294-0001-1Osong Power gel50 mL in 1 POUCHGEL501
81294-0001-2Osong Power gel100 mL in 1 BOTTLEGEL1001
81294-0001-3Osong Power gel500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81294-0001OSONG POWER GEL (ALCOHOL) GEL [OSONG CO., LTD.]1Legacy NDC, 3 package rows20201225_b7448345-efd9-6733-e053-2995a90a11e1.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81294-000181294-0001-1, 81294-0001-2, 81294-0001-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
b744ea20-d390-982b-e053-2a95a90acc00b7448345-efd9-6733-e053-2995a90a11e12020-12-25WarningsExact identifier
spl id: b744ea20-d390-982b-e053-2a95a90acc00
spl set id: b7448345-efd9-6733-e053-2995a90a11e1

Reported adverse events (FAERS/openFDA)#

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