75543-302 V2 - DailyMed Details

75543-302 V2

SPL v2

SPL

SPL Set ID 3ca0168d-8945-907a-e063-6294a90a9deb

Route

TOPICAL

Published

Effective Date 2025-08-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Phenoxyethanol Propylene Glycol Fragrance 13576 Aloe Barbadensis Leaf Polysaccharides Alpha-tocopherol Water Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-18

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

Hand sanitizer to help reduce bacteria;

For use when soap and water are not available.

Stop Use

If irritation or rash occurs.These may be signs of a serious condition.

Warnings

For external use only

Questions

call 718-975-2586

Ask Doctor

If irritation or rash occurs.These may be signs of a serious condition.

Directions

1.Apply to hands,allow to air dry without wiping;

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

Do Not Use

On children less than 2 months old;

On open skin wounds.

When Using

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

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

1.Store in a cool,dry place;

2.Avoid freezing and excessive heat.

Inactive Ingredients

Water,Aloe Barbadensis Leaf Extract,Alpha-Tocopherol,Fragrance,Glycerin,Phenoexyethanol,Propylene Glycol.

Principal Display Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use

Hand sanitizer to help reduce bacteria;

For use when soap and water are not available.

Purpose

Antibacterial

Stop Use

If irritation or rash occurs.These may be signs of a serious condition.

Warnings

For external use only

Questions

call 718-975-2586

Ask Doctor

If irritation or rash occurs.These may be signs of a serious condition.

Directions

1.Apply to hands,allow to air dry without wiping;

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

Do Not Use (Do not use)

On children less than 2 months old;

On open skin wounds.

When Using

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

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information (Other information)

1.Store in a cool,dry place;

2.Avoid freezing and excessive heat.

Inactive Ingredients (Inactive ingredients)

Water,Aloe Barbadensis Leaf Extract,Alpha-Tocopherol,Fragrance,Glycerin,Phenoexyethanol,Propylene Glycol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE BARBADENSIS LEAF POLYSACCHARIDES", "unii": "W21O437517", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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.", "Purpose": "Antibacterial", "Stop Use": "If irritation or rash occurs.These may be signs of a serious condition.", "Warnings": "For external use only", "Questions": "call 718-975-2586", "Ask Doctor": "If irritation or rash occurs.These may be signs of a serious condition.", "Directions": "1.Apply to hands,allow to air dry without wiping; 2.Children under 6 years of age should be supervised when using this product.", "Do not use": "On children less than 2 months old; On open skin wounds.", "When Using": "keep out of eyes,ears,and mouth.In case of contact with eyes,rinse eyes thoroughly with water.", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Other information": "1.Store in a cool,dry place; 2.Avoid freezing and excessive heat.", "Inactive ingredients": "Water,Aloe Barbadensis Leaf Extract,Alpha-Tocopherol,Fragrance,Glycerin,Phenoexyethanol,Propylene Glycol.", "Keep Out Of Reach Of Children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:48.855289 · Updated: 2026-03-14T23:09:49.100948