42003-204 - DailyMed Details

42003-204

SPL v2

SPL

SPL Set ID aedc79b8-ac7d-c790-e053-2995a90aad88

Route

TOPICAL

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Aloe Vera Leaf Chamomile Phenoxyethanol Polysorbate 20 Alpha-tocopherol Acetate Water Lemon

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Use

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Section 50565-1

Keep out of reach of children under 6 years. Store product away from children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

Section 50566-9

Stop use and seek medical attention if rash occurs or irritation persists

Section 50567-7

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

Avoid contact with broken skin.

Stop use and seek medical attention if rash occurs or irritation persists

Keep out of reach of children under 6 years. Store product away from children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

Warnings

For External Use Only.

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

Avoid contact with broken skin.

Stop use and seek medical attention if rash occurs or irritation persists

Keep out of reach of children under 6 years. Store product away from children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

Directions

Allow for hand to remain wet for up to 30 seconds to sanitize and up to a couple minutes to disinfect.

After use discard wipes in trash. Do not flush in the toilet.

Do Not Use

Other Information

Recommended storage temperature: 32°F to 104°F（0°C to 40°C )

Sheet Size: 5.9"x7.9" (15cm*20cm)

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

aloe barbadensis leaf juice, fragrance, phenoxyethanol, polysorbate 20, propylene glycol, tocopheryl acetate, water.

Package Label Principal Display Panel

Structured Label Content

Use

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years. Store product away from children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and seek medical attention if rash occurs or irritation persists

Section 50567-7 (50567-7)

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

Avoid contact with broken skin.

Stop use and seek medical attention if rash occurs or irritation persists

Keep out of reach of children under 6 years. Store product away from children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

Purpose

Antimicrobial

Warnings

For External Use Only.

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

Avoid contact with broken skin.

Stop use and seek medical attention if rash occurs or irritation persists

Keep out of reach of children under 6 years. Store product away from children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

Directions

Allow for hand to remain wet for up to 30 seconds to sanitize and up to a couple minutes to disinfect.

After use discard wipes in trash. Do not flush in the toilet.

Do Not Use (Do not use)

Other Information (Other information)

Recommended storage temperature: 32°F to 104°F（0°C to 40°C )

Sheet Size: 5.9"x7.9" (15cm*20cm)

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, fragrance, phenoxyethanol, polysorbate 20, propylene glycol, tocopheryl acetate, water.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEMON", "unii": "24RS0A988O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand washing to decrease bacteria on the skin. Recommended for repeat use.", "50565-1": "Keep out of reach of children under 6 years. Store product away from children. If swallowed, seek medical attention or contact a Poison Control Center immediately.", "50566-9": "Stop use and seek medical attention if rash occurs or irritation persists", "50567-7": "When using this product, avoid contact with eyes. If contact or irritation occurs, rinse eyes thoroughly with water. Avoid contact with broken skin. Stop use and seek medical attention if rash occurs or irritation persists Keep out of reach of children under 6 years. Store product away from children. If swallowed, seek medical attention or contact a Poison Control Center immediately.", "Purpose": "Antimicrobial", "Warnings": "For External Use Only. When using this product, avoid contact with eyes. If contact or irritation occurs, rinse eyes thoroughly with water. Avoid contact with broken skin. Stop use and seek medical attention if rash occurs or irritation persists Keep out of reach of children under 6 years. Store product away from children. If swallowed, seek medical attention or contact a Poison Control Center immediately.", "Directions": "Allow for hand to remain wet for up to 30 seconds to sanitize and up to a couple minutes to disinfect. After use discard wipes in trash. Do not flush in the toilet.", "Do not use": "/", "Other information": "Recommended storage temperature: 32°F to 104°F（0°C to 40°C ) Sheet Size: 5.9"x7.9" (15cm*20cm)", "Active Ingredient(s)": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "aloe barbadensis leaf juice, fragrance, phenoxyethanol, polysorbate 20, propylene glycol, tocopheryl acetate, water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:07.861922 · Updated: 2026-03-14T23:00:28.895348