a646a31f-cb47-173e-e053-2995a90a9f68

SPL v3

SPL

SPL Set ID a646a31f-cb47-173e-e053-2995a90a9f68

Route

topical

Published

Effective Date 2020-05-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.3 g)

Inactive Ingredients

propylene glycol phenoxyethanol didecyldimonium chloride water chlorphenesin

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2020-05-23

Purpose

Antiseptic

Description

Drug Facts

Medication Information

Warnings

Keep away from fire and flames.For external use only.

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry 20-30 seconds.Do not dry or wipe when finished.

Other Information

The espiry date is stated on the packaging.Store at -20℃ to+30℃,away from sunlight.

Inactive Ingredients

Water，Propylene Glycol，DidecyldimoniumChloride ，Phenoxyethanol， Chlorphenesin.

Description

Drug Facts

Use

Use for hand-washing to decrease bacteria on the skin when water is not available.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed,get medical help or contact poison control center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develop.

Section 50567-7

When using this product ,do not get in eyes.

Do Not Use

Do not use on open or broken skin.If contact occurs,rinse eyes thoroughly with water.

Active Ingredient(s)

Benzalkonium Chloride 0.3%

Package Label Principal Display Panel

Structured Label Content

Warnings

Keep away from fire and flames.For external use only.

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry 20-30 seconds.Do not dry or wipe when finished.

Other Information (Other information)

The espiry date is stated on the packaging.Store at -20℃ to+30℃,away from sunlight.

Inactive Ingredients (Inactive ingredients)

Water，Propylene Glycol，DidecyldimoniumChloride ，Phenoxyethanol， Chlorphenesin.

Use

Use for hand-washing to decrease bacteria on the skin when water is not available.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed,get medical help or contact poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop.

Section 50567-7 (50567-7)

When using this product ,do not get in eyes.

Do Not Use (Do not use)

Do not use on open or broken skin.If contact occurs,rinse eyes thoroughly with water.

Active Ingredient(s)

Benzalkonium Chloride 0.3%

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

[{"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIDECYLDIMONIUM CHLORIDE", "unii": "JXN40O9Y9B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CHLORPHENESIN", "unii": "I670DAL4SZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Use for hand-washing to decrease bacteria on the skin when water is not available.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.If swallowed,get medical help or contact poison control center right away.", "50566-9": "Stop use and ask a doctor if irritation and redness develop.", "50567-7": "When using this product ,do not get in eyes.", "Purpose": "Antiseptic", "Warnings": "Keep away from fire and flames.For external use only.", "Directions": "Wet hands thoroughly with product and allow to dry 20-30 seconds.Do not dry or wipe when finished.", "Do not use": "Do not use on open or broken skin.If contact occurs,rinse eyes thoroughly with water.", "Other information": "The espiry date is stated on the packaging.Store at -20℃ to+30℃,away from sunlight.", "Active Ingredient(s)": "Benzalkonium Chloride 0.3%", "Inactive ingredients": "Water，Propylene Glycol，DidecyldimoniumChloride ，Phenoxyethanol， Chlorphenesin."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:23.623060 · Updated: 2026-03-14T23:01:53.224533