Fusion Antibacterial Wipes

SPL v4

SPL

SPL Set ID b2c53fa7-a74f-8fc1-e053-2a95a90a8942

Route

TOPICAL

Published

Effective Date 2020-10-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.0013 1)

Inactive Ingredients

Water Glycerin Aloe Vera Leaf Decyl Glucoside

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-10-23

Description

Benzalkonium Chloride 0.13% w/w

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13% w/w

Uses

For hand washing to decrease bacteria on the skin.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51945-4

70 WIPES, NDC: 80336-004-09

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

Apply to clean dry hands.

Wet hands thoroughly with the product and allow to dry

Children under 6 should be supervised when using this product

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Other Information

Do not store above 104°F (40°C)

Do not use if seal is missing or broken

Inactive Ingredients

aloe barbadensis leaf juice, decyl glucoside, glycerin, water.

Structured Label Content

Uses

For hand washing to decrease bacteria on the skin.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

70 WIPES, NDC: 80336-004-09

Purpose

Antiseptic

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

Apply to clean dry hands.

Wet hands thoroughly with the product and allow to dry

Children under 6 should be supervised when using this product

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13% w/w

Other Information (Other information)

Do not store above 104°F (40°C)

Do not use if seal is missing or broken

Inactive Ingredients

aloe barbadensis leaf juice, decyl glucoside, glycerin, water.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.0013", "strengthDenominator": "1", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DECYL GLUCOSIDE", "unii": "Z17H97EA6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand washing to decrease bacteria on the skin.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash appears and lasts", "50567-7": "When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "51945-4": "70 WIPES, NDC: 80336-004-09", "Purpose": "Antiseptic", "Warnings": "For external use only When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Directions": "Apply to clean dry hands. Wet hands thoroughly with the product and allow to dry Children under 6 should be supervised when using this product", "Active ingredient": "Benzalkonium Chloride 0.13% w/w", "Other information": "Do not store above 104°F (40°C) Do not use if seal is missing or broken", "Inactive Ingredients": "aloe barbadensis leaf juice, decyl glucoside, glycerin, water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:36.474578 · Updated: 2026-03-14T22:59:41.656939