Purpose Antibacterial Liquid Hand Soap- Refill

SPL v1

SPL

SPL Set ID e819b2b8-c02f-dc32-e053-2995a90ac85d

Route

TOPICAL

Published

Effective Date 2022-09-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (1.3 mg)

Inactive Ingredients

Fd&c Yellow No. 5 Sodium Chloride Anhydrous Citric Acid Edetate Sodium Methylchloroisothiazolinone Water Sodium Laureth Sulfate Cocamidopropyl Betaine Methylisothiazolinone

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2022-09-06

Description

Active Ingredient - Benzalkonium Chloride - 0.13%

Medication Information

Warnings and Precautions

for external use only - hands only

Indications and Usage

Use for handwashing to decrease bacteria on skin

Dosage and Administration

Direction

* wet hands

* apply to hands

* scrub thoroughly

* rinse thoroughly

Description

Active Ingredient - Benzalkonium Chloride - 0.13%

Section 50565-1

keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9

Stop use and ask a doctor if irritation or redness develops and if condition persists for more than 72 hours

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Section 51727-6

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Tetra Sodium EDTA, Methylchloroisothiazolinone, Methylisthiazolinone, Yellow 5, Fragrance (Parfum)

Section 51945-4

Section 55105-1

Purpose - Antibacterial

Section 55106-9

Active Ingredient - Benzalkonium Chloride - 0.13%

Structured Label Content

Indications and Usage (34067-9)

Use for handwashing to decrease bacteria on skin

Dosage and Administration (34068-7)

Direction

* wet hands

* apply to hands

* scrub thoroughly

* rinse thoroughly

Warnings and Precautions (34071-1)

for external use only - hands only

Section 50565-1 (50565-1)

keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops and if condition persists for more than 72 hours

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Section 51727-6 (51727-6)

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Tetra Sodium EDTA, Methylchloroisothiazolinone, Methylisthiazolinone, Yellow 5, Fragrance (Parfum)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose - Antibacterial

Section 55106-9 (55106-9)

Active Ingredient - Benzalkonium Chloride - 0.13%

Advanced Ingredient Data

[{"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE SODIUM", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLCHLOROISOTHIAZOLINONE", "unii": "DEL7T5QRPN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURETH SULFATE", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLISOTHIAZOLINONE", "unii": "229D0E1QFA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use for handwashing to decrease bacteria on skin", "34068-7": "Direction * wet hands * apply to hands * scrub thoroughly * rinse thoroughly", "34071-1": "for external use only - hands only", "50565-1": "keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately", "50566-9": "Stop use and ask a doctor if irritation or redness develops and if condition persists for more than 72 hours", "50567-7": "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water", "51727-6": "Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Tetra Sodium EDTA, Methylchloroisothiazolinone, Methylisthiazolinone, Yellow 5, Fragrance (Parfum)", "55105-1": "Purpose - Antibacterial", "55106-9": "Active Ingredient - Benzalkonium Chloride - 0.13%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:18.109032 · Updated: 2026-03-14T23:00:41.107943