OSONG ANTISEPTIC ALCOHOL- alcohol liquid 
Osong Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

alcohol

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

■ instant hand antiseptic to decrease bacteria on the skin

KEEP OUT OF REACH OF THE CHILDREN

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

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.

for external use only

water

label

OSONG ANTISEPTIC ALCOHOL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81294-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL83 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81294-0003-1500 mL in 1 POUCH; Type 0: Not a Combination Product12/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/25/2020
Labeler - Osong Co., Ltd. (687859804)
Registrant - Osong Co., Ltd. (687859804)
Establishment
NameAddressID/FEIBusiness Operations
Osong Co., Ltd.687859804manufacture(81294-0003)

Revised: 12/2020
Document Id: b746a70f-855c-7c39-e053-2995a90a26a6
Set id: b746a70f-855b-7c39-e053-2995a90a26a6
Version: 1
Effective Time: 20201225
 
Osong Co., Ltd.