42003-205 - DailyMed Details

42003-205

SPL v2

SPL

SPL Set ID aedd573c-6981-3c25-e053-2a95a90af0f5

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

water aloe vera leaf chamomile phenoxyethanol polysorbate 20 alpha-tocopherol acetate lemon

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-30

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Medication Information

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.

Purpose

Antimicrobial

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.

Other Information

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

Sheet Size: 5.7"x7.1" (14.5cm*18cm)

Inactive Ingredients

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

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.

Do Not Use

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Package Label Principal Display Panel

Structured Label Content

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.

Purpose

Antimicrobial

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.

Other Information (Other information)

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

Sheet Size: 5.7"x7.1" (14.5cm*18cm)

Inactive Ingredients (Inactive ingredients)

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

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.

Do Not Use (Do not use)

Active Ingredient(s)

Benzalkonium Chloride 0.13%

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

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "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: 5.7"x7.1" (14.5cm*18cm)", "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: 2026-02-15T12:00:07.863478 · Updated: 2026-03-14T23:00:28.895348