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SPL v3

SPL

SPL Set ID 27f4ff15-5480-8842-e063-6294a90ad35b

Route

TOPICAL

Published

Effective Date 2024-11-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Sodium Laureth Sulfate Phenoxyethanol Decyl Glucoside Citric Acid Methylisothiazolinone Sodium Benzoate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-27

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

for handwashing, to reduce bacteria on skin

Section 44425-7

Store in a cool and dry pleace, and avoid direct sunlight.

Section 51945-4

Warnings

For external use only.

Directions

Spray to wet hand. Scrub and rinse thoroughly.

Do Not Use

Do not use with chlorine bleach to avoid irritating fumes.

Do Not Ingest

Do not ingest. If ingested, drink plenty of water, contact a physician.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water (Aqua）

Sodium Laureth Sulfate

Decyl Glucoside

Citric Acid

Methylisothiazlione

Phenoxyethanol

Sodium Benzoate

Fragrance

Avoid Contact With Eyes.

If eye contact occures fush thoroughly with water.

Keep Out of Reach of Children

Keep out of reach of children

Structured Label Content

Uses

for handwashing, to reduce bacteria on skin

Section 44425-7 (44425-7)

Store in a cool and dry pleace, and avoid direct sunlight.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings

For external use only.

Directions

Spray to wet hand. Scrub and rinse thoroughly.

Do Not Use (Do not use)

Do not use with chlorine bleach to avoid irritating fumes.

Do Not Ingest (Do not ingest)

Do not ingest. If ingested, drink plenty of water, contact a physician.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water (Aqua）

Sodium Laureth Sulfate

Decyl Glucoside

Citric Acid

Methylisothiazlione

Phenoxyethanol

Sodium Benzoate

Fragrance

Avoid Contact With Eyes. (Avoid contact with eyes.)

If eye contact occures fush thoroughly with water.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

Advanced Ingredient Data

[{"name": "SODIUM LAURETH SULFATE", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DECYL GLUCOSIDE", "unii": "Z17H97EA6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLISOTHIAZOLINONE", "unii": "229D0E1QFA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for handwashing, to reduce bacteria on skin", "44425-7": "Store in a cool and dry pleace, and avoid direct sunlight.", "Purpose": "Antibacterial", "Warnings": "For external use only.", "Directions": "Spray to wet hand. Scrub and rinse thoroughly.", "Do not use": "Do not use with chlorine bleach to avoid irritating fumes.", "Do not ingest": "Do not ingest. If ingested, drink plenty of water, contact a physician.", "Active ingredient": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water (Aqua） Sodium Laureth Sulfate Decyl Glucoside Citric Acid Methylisothiazlione Phenoxyethanol Sodium Benzoate Fragrance", "Avoid contact with eyes.": "If eye contact occures fush thoroughly with water.", "Keep out of reach of children": "Keep out of reach of children"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:40.853231 · Updated: 2026-03-14T23:07:51.764628