75543-301-01

75543-301-01
SPL v1
SPL
SPL Set ID 38381a41-db33-45c6-e063-6394a90a2317
Route
TOPICAL
Published
Effective Date 2025-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Propylene Glycol Aloe Barbadensis Leaf Phenoxyethanol Water Glycerin Alpha-tocopherol Fragrance 13576

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-23

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

In 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

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

Principal Display Panel

75543-301-01

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)

In 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)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

75543-301-01

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


Raw Label Data

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