O2 PATCH (ko2, ca- oh2 powder

O2 Patch by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

KO2

INACTIVE INGREDIENT

Ca(OH)2, water

PURPOSE

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

WARNINGS

■ 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

Keep Out of Reach of Children.

INDICATIONS & USAGE

attach a patch where needed

DOSAGE & ADMINISTRATION

for topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

O2 PATCH 
ko2, ca(oh)2 powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81944-0002
Route of Administration	RESPIRATORY (INHALATION)

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 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81944-0002-1	0.5 g in 1 PATCH; Type 0: Not a Combination Product	06/12/2021

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

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(81944-0002)