1426f295-94ac-bf26-e063-6294a90a5820

SPL v5

SPL

SPL Set ID 1426f295-94ac-bf26-e063-6294a90a5820

Route

topical

Published

Effective Date 2025-04-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.2 mg)

Inactive Ingredients

cocamidopropyl betaine chlorhexidine digluconate sodium chloride sodium laureth sulfate glycerin water hydrogen peroxide sodium benzoate citric acid

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-04-18

Description

Active ingredient ....................... Purpose Benzalkonium Chloride 0.2% .... Antibacterial

Medication Information

Warnings

For extrenal use only.

Avoid contact with eyes.

Indications and Usage

When using this product

In case of eye contact, rinse thoroughly with water.

Directions

Apply foam on dry hands, lather for 30 seconds and rinse with water thoroughly.

Suitable for use with a foaming pump.

Description

Active ingredient ....................... Purpose Benzalkonium Chloride 0.2% .... Antibacterial

Use

For handwashing. Helps decrease bacteria on the skin.

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 51727-6

Water (Aqua), Sodium Lauryl Ether Sulfate (SLES), Cocamidopropyl Betaine, Hydrogen Peroxide, Chlorhexidine Bigluconate, Glycerin, Sodium Chloride, Sodium Benzoate, Citric Acid, Fragrance.

Section 51945-4

Storage

Store below 86 ⁰ F (30 ⁰ C).

Drug Facts

Active ingredient ....................... Purpose

Benzalkonium Chloride 0.2% .... Antibacterial

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 extrenal use only.

Avoid contact with eyes.

Indications and Usage (34067-9)

When using this product

In case of eye contact, rinse thoroughly with water.

Directions

Apply foam on dry hands, lather for 30 seconds and rinse with water thoroughly.

Suitable for use with a foaming pump.

Use

For handwashing. Helps decrease bacteria on the skin.

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 51727-6 (51727-6)

Water (Aqua), Sodium Lauryl Ether Sulfate (SLES), Cocamidopropyl Betaine, Hydrogen Peroxide, Chlorhexidine Bigluconate, Glycerin, Sodium Chloride, Sodium Benzoate, Citric Acid, Fragrance.

Section 51945-4 (51945-4)

Storage

Store below 86 ⁰ F (30 ⁰ C).

Drug Facts

Active ingredient ....................... Purpose

Benzalkonium Chloride 0.2% .... Antibacterial

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": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORHEXIDINE DIGLUCONATE", "unii": "MOR84MUD8E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURETH SULFATE", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For handwashing. Helps decrease bacteria on the skin.", "34067-9": "When using this product In case of eye contact, rinse 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.", "51727-6": "Water (Aqua), Sodium Lauryl Ether Sulfate (SLES), Cocamidopropyl Betaine, Hydrogen Peroxide, Chlorhexidine Bigluconate, Glycerin, Sodium Chloride, Sodium Benzoate, Citric Acid, Fragrance.", "Storage": "Store below 86 0 F (30 0 C).", "Warnings": "For extrenal use only. Avoid contact with eyes.", "Directions": "Apply foam on dry hands, lather for 30 seconds and rinse with water thoroughly. Suitable for use with a foaming pump.", "Drug Facts": "Active ingredient ....................... Purpose Benzalkonium Chloride 0.2% .... Antibacterial", "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: 2026-02-15T12:06:04.519406 · Updated: 2026-03-14T23:08:36.803157