O2 Patch by O2 Korea Co., Ltd.

O2 Patch by

Drug Labeling and Warnings

O2 Patch by is a Otc medication manufactured, distributed, or labeled by O2 Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

O2 PATCH- ko2, ca(oh)2 liquid 
DIGENT BIO Co., Ltd.

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.

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KO2

Ca(OH)2, water

Corona virus, Sterilization, antibacterial, deodorant, fragrance, oxygen supply

■ 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 one areas that have been medically treated with a cast or bandage.

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

Keep Out of Reach of Children.

attach a patch where needed

for topical use only

O2 PATCH 
ko2, ca(oh)2 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81944-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM HYDROXIDE (UNII: PF5DZW74VN) (CALCIUM HYDROXIDE - UNII:PF5DZW74VN)	CALCIUM HYDROXIDE	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81944-0001-1	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/25/2021	12/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/12/2021	12/25/2021

Labeler - DIGENT BIO Co., Ltd. (695157170)

Registrant - DIGENT BIO Co., Ltd. (695157170)

Establishment
Name	Address	ID/FEI	Business Operations
DIGENT BIO Co., Ltd.		695157170	manufacture(81944-0001)

Revised: 4/2023

Document Id: fa1f922d-33a8-fbf8-e053-6394a90af9ef

34390-5

Set id: c49269d2-8e7b-25e6-e053-2a95a90a74aa

Version: 4

Effective Time: 20230424