ANTISEPTIC- alcohol liquid
I MEDISON 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

Water

to desrease bacteria on hands.

KEEP OUT OF REACH OF THE CHILDREN

Pump a small amount of product into palm of hand.
Rub thoroughly over all surfaces of both hands for 15 seconds.

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

for external use only

label

ANTISEPTIC
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74650-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	83 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74650-0001-1	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
2	NDC:74650-0001-2	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/01/2020

Labeler - I MEDISON CO., LTD. (693902373)

Registrant - I MEDISON CO., LTD. (693902373)

Name	Address	ID/FEI	Business Operations
Establishment
I MEDISON CO., LTD.		693902373	manufacture(74650-0001)

Revised: 4/2020

Document Id: a3334101-58c7-c003-e053-2a95a90ac8e9

Set id: a31295f4-1449-0c82-e053-2a95a90a9087

Version: 2

Effective Time: 20200413

I MEDISON CO., LTD.