Lance Global Gimpo Branch

SPL v1

SPL

SPL Set ID b8cf1f21-f237-6f5d-e053-2a95a90a33e8

Route

TOPICAL

Published

Effective Date 2021-01-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Water Phenoxyethanol Polysorbate 80

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-01-14

Description

benzalkonium chloride

Medication Information

Warnings and Precautions

For external use only

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

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

Indications and Usage

wet hands throughly with product and allow to dry

children unser 6 years of age should be supervised

discard wip in trash receptacle after use, do not flush

Dosage and Administration

for external use only

Description

benzalkonium chloride

Section 50565-1

keep out of reach of the children

Section 51727-6

water, diglycerin, fragrance (parfum), polysorbate 80, phenoxyethanol

Section 51945-4

Section 55105-1

hand sanitizer to help reduce bacteria on the skin

Section 55106-9

benzalkonium chloride

Structured Label Content

Indications and Usage (34067-9)

wet hands throughly with product and allow to dry

children unser 6 years of age should be supervised

discard wip in trash receptacle after use, do not flush

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

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

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

water, diglycerin, fragrance (parfum), polysorbate 80, phenoxyethanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

hand sanitizer to help reduce bacteria on the skin

Section 55106-9 (55106-9)

benzalkonium chloride

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "wet hands throughly with product and allow to dry children unser 6 years of age should be supervised discard wip in trash receptacle after use, do not flush", "34068-7": "for external use only", "34071-1": "For external use only Do not use in children less than 2 months of age on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "keep out of reach of the children", "51727-6": "water, diglycerin, fragrance (parfum), polysorbate 80, phenoxyethanol", "55105-1": "hand sanitizer to help reduce bacteria on the skin", "55106-9": "benzalkonium chloride"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:17.880726 · Updated: 2026-03-14T22:59:11.576282