334a2d36-985a-01b7-e063-6394a90ad615

SPL v2
SPL
SPL Set ID 334a2d36-985a-01b7-e063-6394a90ad615
Route
topical
Published
Effective Date 2025-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (55 mL) isopropyl alcohol (17 mL)
Inactive Ingredients
chlorhexidine digluconate peg-10 dimethicone (220 cst) caprylyl/capryl glucoside glycerin water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-18

Description

Active ingredients................. Purpose Ethyl Alcohol 55% v/v ...........Antimicrobial Isopropyl Alcohol 17% v/v......Antimicrobial


Medication Information

Warnings

For external use only. Avoid contact with eyes.

Indications and Usage

When using this product

In case of eye contact, rinse eyes thoroughly with water.

Directions

Apply at least 3 ml of the agent to dry hands and rub into the skin until completely vanished but not less than 30 seconds, paying attention to the thoroughness of the hand skin treatment between the fingers and fingertips.

Suitable for use with a foaming pump.

Other Information

Flammable. Keep away from fire and flame.

Store below 86 0 F (30 0 C).

Inactive Ingredients

Water (Aqua), Chlorhexidine Bigluconate, PEG-10 Dimethicone, Capryl Glucoside, Glycerin.

Description

Active ingredients................. Purpose Ethyl Alcohol 55% v/v ...........Antimicrobial Isopropyl Alcohol 17% v/v......Antimicrobial

Use

Hand sanitizer for operating rooms and medical environments.

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Section 50569-3

Stop use and ask a doctor

If irritation or rash develops.

Section 51945-4

Drug Facts

Active ingredients................. Purpose

Ethyl Alcohol 55% v/v ...........Antimicrobial

Isopropyl Alcohol 17% v/v......Antimicrobial

Questions Or Comments

Email: [email protected], Tel.: +374 12 30 58 00

Manufacturer

Babikian Healthcare Products, CJSC.

Gevorg Chaush Hwy 90 - Republic of Armenia

Website: www.bhp.am


Structured Label Content

Warnings

For external use only. Avoid contact with eyes.

Indications and Usage (34067-9)

When using this product

In case of eye contact, rinse eyes thoroughly with water.

Directions

Apply at least 3 ml of the agent to dry hands and rub into the skin until completely vanished but not less than 30 seconds, paying attention to the thoroughness of the hand skin treatment between the fingers and fingertips.

Suitable for use with a foaming pump.

Other Information (Other information)

Flammable. Keep away from fire and flame.

Store below 86 0 F (30 0 C).

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Chlorhexidine Bigluconate, PEG-10 Dimethicone, Capryl Glucoside, Glycerin.

Use

Hand sanitizer for operating rooms and medical environments.

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Section 50569-3 (50569-3)

Stop use and ask a doctor

If irritation or rash develops.

Section 51945-4 (51945-4)

Drug Facts

Active ingredients................. Purpose

Ethyl Alcohol 55% v/v ...........Antimicrobial

Isopropyl Alcohol 17% v/v......Antimicrobial

Questions Or Comments (Questions or Comments)

Email: [email protected], Tel.: +374 12 30 58 00

Manufacturer

Babikian Healthcare Products, CJSC.

Gevorg Chaush Hwy 90 - Republic of Armenia

Website: www.bhp.am


Advanced Ingredient Data


Raw Label Data

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