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SPL v2

SPL

SPL Set ID 339738c4-169d-6299-e063-6394a90afb58

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

Water Glycerin Hydrogen Peroxide

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

Indications and Usage

When using this product

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

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

Warnings

For external use only. Avoid contact with eyes.

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.

Drug Facts

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

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

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

Other Information

Flammable. Keep away from fire and flame.

Store below 86 ⁰ F (30 ⁰ C).

Inactive Ingredients

Water (Aqua), Glycerin, Hydrogen Peroxide.

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

Use

Hand sanitizer for operating rooms and medical environments.

Indications and Usage (34067-9)

When using this product

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

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)

Warnings

For external use only. Avoid contact with eyes.

Directions

Drug Facts

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

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

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

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), Glycerin, Hydrogen Peroxide.

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

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "55", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "17", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer for operating rooms and medical environments.", "34067-9": "When using this product In case of eye contact, rinse eyes thoroughly with water.", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact Poison Control Center right away.", "50569-3": "Stop use and ask a doctor If irritation or rash develops.", "Warnings": "For external use only. Avoid contact with eyes.", "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.", "Drug Facts": "Active ingredients................. Purpose Ethyl Alcohol 55% v/v ...........Antimicrobial Isopropyl Alcohol 17% v/v......Antimicrobial", "Other information": "Flammable. Keep away from fire and flame. Store below 86 0 F (30 0 C).", "Inactive ingredients": "Water (Aqua), Glycerin, Hydrogen Peroxide.", "Questions or Comments": "Email: info@bhp.am, Tel.: +374 12 30 58 00 Manufacturer Babikian Healthcare Products, CJSC. Gevorg Chaush Hwy 90 - Republic of Armenia Website: www.bhp.am"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:04.534308 · Updated: 2026-03-14T23:08:36.803157