80800-002 wipes

SPL v2

SPL

SPL Set ID 2f3f86f8-2893-4150-b715-36b1146a267a

Route

topical

Published

Effective Date 2021-03-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.13 g)

Inactive Ingredients

water citric acid monohydrate propylene glycol diazolidinyl urea iodopropynyl butylcarbamate

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2021-03-12

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

When using this product, keep out of eyes, ears or mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs, these may be signs of a serious condition.

Purpose

Antibacterial

Directions

Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

Store in a cool, dry area. Keep container closed when not in use. Dispose of used wipes in trash bin. Do not flush.

Inactive Ingredients

Water, Fragrance, Citric Acid, Propylene Glycol, Polyoxyethylene Alkyl Ether, Diazolidinyl Urea, Iodopropynyl Butylcarbamate

Description

Benzalkonium Chloride 0.13%

Use

For use when soap and water are not available

Section 50565-1

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

Section 51945-4

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Structured Label Content

Warnings

For external use only.

When using this product, keep out of eyes, ears or mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs, these may be signs of a serious condition.

Purpose

Antibacterial

Directions

Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

Store in a cool, dry area. Keep container closed when not in use. Dispose of used wipes in trash bin. Do not flush.

Inactive Ingredients (Inactive ingredients)

Water, Fragrance, Citric Acid, Propylene Glycol, Polyoxyethylene Alkyl Ether, Diazolidinyl Urea, Iodopropynyl Butylcarbamate

Use

For use when soap and water are not available

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODOPROPYNYL BUTYLCARBAMATE", "unii": "603P14DHEB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "For use when soap and water are not available", "50565-1": "Keep out of reach of children. If swallowed, get immediate medical help or contact a Poison Control Center right away.", "Purpose": "Antibacterial", "Warnings": "For external use only. When using this product, keep out of eyes, ears or mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs, these may be signs of a serious condition.", "Directions": "Supervise children under 6 years of age when using this product to avoid swallowing", "Other Information": "Store in a cool, dry area. Keep container closed when not in use. Dispose of used wipes in trash bin. Do not flush.", "Active Ingredient(s)": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water, Fragrance, Citric Acid, Propylene Glycol, Polyoxyethylene Alkyl Ether, Diazolidinyl Urea, Iodopropynyl Butylcarbamate"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:29.226442 · Updated: 2026-03-14T22:59:29.411693