77765-015 - DailyMed Details

77765-015

SPL v2

SPL

SPL Set ID af18d0e1-aae0-49ea-e053-2995a90a4960

Route

TOPICAL

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Propylene Glycol Aloe Vera Leaf Water .alpha.-tocopherol Acetate Glycerin Edetate Disodium Phenoxyethanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-09-12

Description

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Use

For hand washing to decrease bacteria on the skin

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

irritation and redness develop

condition persists for, more than 72 hours

Section 50567-7

Stop use and ask a doctor if

irritation and redness develop

condition persists for, more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only

Do not use in the eyes

Stop use and ask a doctor if

irritation and redness develop

condition persists for, more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping

Do Not Use

Do not use in the eyes

Other Information

Active Ingredient(s)

Benzalkonium chloride 0.13%

Inactive Ingredients

Water, glycerin, propylene glycol, EDTA disodium salt, phenoxyethanol, aloe vera leaf juice, tocopheryl acetate.

Package Label Principal Display Panel

Structured Label Content

Use

For hand washing to decrease bacteria on the skin

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

irritation and redness develop

condition persists for, more than 72 hours

Section 50567-7 (50567-7)

Stop use and ask a doctor if

irritation and redness develop

condition persists for, more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic

Warnings

For external use only

Do not use in the eyes

Stop use and ask a doctor if

irritation and redness develop

condition persists for, more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping

Do Not Use (Do not use)

Do not use in the eyes

Other Information (Other information)

Active Ingredient(s)

Benzalkonium chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, glycerin, propylene glycol, EDTA disodium salt, phenoxyethanol, aloe vera leaf juice, tocopheryl acetate.

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": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "1"}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand washing to decrease bacteria on the skin", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation and redness develop condition persists for, more than 72 hours", "50567-7": "Stop use and ask a doctor if irritation and redness develop condition persists for, more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Antiseptic", "Warnings": "For external use only Do not use in the eyes Stop use and ask a doctor if irritation and redness develop condition persists for, more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Directions": "wet hands thoroughly with product and allow to dry without wiping", "Do not use": "Do not use in the eyes", "Other information": "/", "Active Ingredient(s)": "Benzalkonium chloride 0.13%", "Inactive ingredients": "Water, glycerin, propylene glycol, EDTA disodium salt, phenoxyethanol, aloe vera leaf juice, tocopheryl acetate."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:43.892751 · Updated: 2026-03-14T22:58:25.167285