Label: OSONG ANTISEPTIC ALCOHOL- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 81294-0003-1 - Packager: Osong Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 25, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OSONG ANTISEPTIC ALCOHOL
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81294-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 83 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81294-0003-1 500 mL in 1 POUCH; Type 0: Not a Combination Product 12/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/25/2020 Labeler - Osong Co., Ltd. (687859804) Registrant - Osong Co., Ltd. (687859804) Establishment Name Address ID/FEI Business Operations Osong Co., Ltd. 687859804 manufacture(81294-0003)