Antibacterial Lotion Tissue

SPL v2

SPL

SPL Set ID b9dedc8b-0d43-e535-e053-2995a90ab3b0

Route

TOPICAL

Published

Effective Date 2021-01-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (1.3 mg)

Inactive Ingredients

Glycerin Water Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-01-29

Description

DRUG FACTS

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

DRUG FACTS

Use

To help reduce bacteria on the skin that potentially can cause disease.

Section 42229-5

DRUG FACTS

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 occurs. These may be signs of serious condition.

Section 50567-7

When using this product avoid contacting with eyes. In case of eye contact rinse eyes thoroughly with water.

Warnings

For external use only.

Directions

Apply to face, nose and hands. Discard after use.

Children under 6 years of age should be supervised when using this product.

Do Not Use

Do not use if you are allergic to any of the ingredients.

How to Uses

Bag

Tear off the middle line of the bag and open the bag then take out of one sheet to use.Dispose the tissue to the trash bin after wiping.

Box

Open the box, take out of tissue as required.

Dispose it to the trash bin after use.

Active Ingredient(s)

Benzalkonium chloride 0.13%

Inactive Ingredients

Water, Glycerin, Aloe Barbadensis leaf extract.

Package Label Principal Display Panel

NDC:52489-003-01

NDC:52489-003-02

NDC:52489-003-03

Structured Label Content

Use

To help reduce bacteria on the skin that potentially can cause disease.

Section 42229-5 (42229-5)

DRUG FACTS

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 occurs. These may be signs of serious condition.

Section 50567-7 (50567-7)

When using this product avoid contacting with eyes. In case of eye contact rinse eyes thoroughly with water.

Purpose

Antiseptic

Warnings

For external use only.

Directions

Apply to face, nose and hands. Discard after use.

Children under 6 years of age should be supervised when using this product.

Do Not Use (Do not use)

Do not use if you are allergic to any of the ingredients.

How to Uses (How to uses)

Bag

Tear off the middle line of the bag and open the bag then take out of one sheet to use.Dispose the tissue to the trash bin after wiping.

Box

Open the box, take out of tissue as required.

Dispose it to the trash bin after use.

Active Ingredient(s)

Benzalkonium chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Aloe Barbadensis leaf extract.

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

NDC:52489-003-01

NDC:52489-003-02

NDC:52489-003-03

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "To help reduce bacteria on the skin that potentially can cause disease.", "42229-5": "DRUG FACTS", "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 occurs. These may be signs of serious condition.", "50567-7": "When using this product avoid contacting with eyes. In case of eye contact rinse eyes thoroughly with water.", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "Apply to face, nose and hands. Discard after use. Children under 6 years of age should be supervised when using this product.", "Do not use": "Do not use if you are allergic to any of the ingredients.", "How to uses": "Bag Tear off the middle line of the bag and open the bag then take out of one sheet to use.Dispose the tissue to the trash bin after wiping. Box Open the box, take out of tissue as required. Dispose it to the trash bin after use.", "Active Ingredient(s)": "Benzalkonium chloride 0.13%", "Inactive ingredients": "Water, Glycerin, Aloe Barbadensis leaf extract.", "Package Label - Principal Display Panel": "NDC:52489-003-01 NDC:52489-003-02 NDC:52489-003-03"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:22.565470 · Updated: 2026-03-14T23:01:53.224533