87215-001 - DailyMed Details

87215-001

SPL v1

SPL

SPL Set ID 4415ca9f-10b1-88f7-e063-6294a90a2e09

Route

TOPICAL

Published

Effective Date 2025-11-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.1 g)

Inactive Ingredients

Scutellaria Baicalensis Whole Simiarenol Anemonin Water Phillyrin Rose Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-21

Description

Benzalkonium chloride 0.1%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium chloride 0.1%

Use

Hand Santizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Inactive

Forsythia, Scutellaria baicalensis, honeysuckle, Pulsatilla, Purified water, Damascus Rose

Stop Use

Stop use and ask a doctor if irritation or rash occurs.

These maybe signs of a serious condition.

Warnings

For external use only.

Directions

Pump an appropriate amount into palm, rub evenly

over hands for about 2 minutes, then rinse with clean water if desired.

Do Not Use

If you are allergic to any of the ingredents.

When Using

1.This product is for external use only, Do not take internally.

2.Using without antagonistic drugs.

3.When using this product avoid contact with eyes.

Active Ingredient

Benzalkonium chloride 0.1%

Other Information

Store sealed in a cool, dry place, away from light and moisture.

Shelf life: 2 years

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children.lfswallowed, get

medical help or contact a Poison Control Center right away.

Structured Label Content

Use

Hand Santizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Antimicrobial

Inactive (INACTIVE)

Forsythia, Scutellaria baicalensis, honeysuckle, Pulsatilla, Purified water, Damascus Rose

Stop Use

Stop use and ask a doctor if irritation or rash occurs.

These maybe signs of a serious condition.

Warnings

For external use only.

Directions

Pump an appropriate amount into palm, rub evenly

over hands for about 2 minutes, then rinse with clean water if desired.

Do Not Use (Do not use)

If you are allergic to any of the ingredents.

When Using

1.This product is for external use only, Do not take internally.

2.Using without antagonistic drugs.

3.When using this product avoid contact with eyes.

Active Ingredient

Benzalkonium chloride 0.1%

Other Information (Other information)

Store sealed in a cool, dry place, away from light and moisture.

Shelf life: 2 years

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children.lfswallowed, get

medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SCUTELLARIA BAICALENSIS WHOLE", "unii": "6YF0M477I5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SIMIARENOL", "unii": "6OU4M247SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANEMONIN", "unii": "G99XG5B674", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHILLYRIN", "unii": "VE9P4964MG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSE OIL", "unii": "WUB68Y35M7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand Santizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "Purpose": "Antimicrobial", "INACTIVE": "Forsythia, Scutellaria baicalensis, honeysuckle, Pulsatilla, Purified water, Damascus Rose", "Stop Use": "Stop use and ask a doctor if irritation or rash occurs. These maybe signs of a serious condition.", "Warnings": "For external use only.", "Directions": "Pump an appropriate amount into palm, rub evenly over hands for about 2 minutes, then rinse with clean water if desired.", "Do not use": "If you are allergic to any of the ingredents.", "When Using": "1.This product is for external use only, Do not take internally. 2.Using without antagonistic drugs. 3.When using this product avoid contact with eyes.", "Active Ingredient": "Benzalkonium chloride 0.1%", "Other information": "Store sealed in a cool, dry place, away from light and moisture. Shelf life: 2 years", "Keep Out Of Reach Of Children": "Keep out of reach of children.lfswallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:18.920229 · Updated: 2026-03-14T23:10:35.893664