5oct Antibacterl Hand Wipes

SPL v1

SPL

SPL Set ID 3dbd8ca9-1ca0-ac4f-e063-6394a90a3cfa

Route

TOPICAL

Published

Effective Date 2025-09-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

.alpha.-tocopherol Acetate, D- Propylene Glycol Aloe Barbadensis Leaf Glycerin Phenoxyethanol Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Use

Hand sanitizer to help reduce bacteria.

For use when soap and water are not available.

Section 50565-1

Keep out of reach of children. lf 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 a serious condition.

Section 50567-7

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Warnings

For external use only.

Directions

Apply to hands, allow to air dry without wiping.

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

Do Not Use

in children less than 2 months old.

on open skin wounds.

Other Information

Store below 95°F (35°C). Keep closed tightly.

Avoid freezing and excessive heat.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Phenoxyethanol, Fragrance, Aloe Barbadensis Leaf Extractalky,Tocopheryl Acetate

Package Label Principal Display Panel

50 wipes in 1 bottle NDC: 75181-011-01

Structured Label Content

Use

Hand sanitizer to help reduce bacteria.

For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children. lf 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 a serious condition.

Section 50567-7 (50567-7)

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Purpose

Antimicrobial

Warnings

For external use only.

Directions

Apply to hands, allow to air dry without wiping.

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

Do Not Use (Do not use)

in children less than 2 months old.

on open skin wounds.

Other Information (Other information)

Store below 95°F (35°C). Keep closed tightly.

Avoid freezing and excessive heat.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, Propylene Glycol, Glycerin, Phenoxyethanol, Fragrance, Aloe Barbadensis Leaf Extractalky,Tocopheryl Acetate

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

50 wipes in 1 bottle NDC: 75181-011-01

Advanced Ingredient Data

[{"name": ".ALPHA.-TOCOPHEROL ACETATE, D-", "unii": "A7E6112E4N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALOE BARBADENSIS LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer to help reduce bacteria. For use when soap and water are not available.", "50565-1": "Keep out of reach of children. lf 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 a serious condition.", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Purpose": "Antimicrobial", "Warnings": "For external use only.", "Directions": "Apply to hands, allow to air dry without wiping. Children under 6 years of age should be supervised when using this product.", "Do not use": "in children less than 2 months old. on open skin wounds.", "Other information": "Store below 95°F (35°C). Keep closed tightly. Avoid freezing and excessive heat.", "Active Ingredient(s)": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water, Propylene Glycol, Glycerin, Phenoxyethanol, Fragrance, Aloe Barbadensis Leaf Extractalky,Tocopheryl Acetate", "Package Label - Principal Display Panel": "50 wipes in 1 bottle NDC: 75181-011-01"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:54.366491 · Updated: 2026-03-14T23:09:57.827589