Wc10007 - Antibacterial Foam Soap

SPL v3

SPL

SPL Set ID 18f9c948-74aa-ae19-e063-6294a90a23a1

Route

TOPICAL

Published

Effective Date 2024-05-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (1.3 mg)

Inactive Ingredients

Glycerin Fd&c Yellow No. 5 Aloe Vera Leaf Fd&c Red No. 40 Methylchloroisothiazolinone Anhydrous Citric Acid Water Lauramine Oxide Methylisothiazolinone Tetrasodium Glutamate Diacetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-21

Description

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13% w/w

Uses

Antibacterial skin cleanser

Effective in destroying harful bacteria to prevent antibacterial cleansing

Label

Warnings

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

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

Directions

Read entire label before using this product.

Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.

Scrub thoroughly for 20 seconds and rinse with clean water.

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, FD&C Red 40, FD&C Yellow 5, Fragrance, Glycerin, Laurmine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium Glutamate Diacetate, Water

Keep Out of Reach of Children

Keep out of the reach of children

Structured Label Content

Uses

Antibacterial skin cleanser

Effective in destroying harful bacteria to prevent antibacterial cleansing

Label

Purpose

Antibacterial

Warnings

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

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

Directions

Read entire label before using this product.

Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.

Scrub thoroughly for 20 seconds and rinse with clean water.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13% w/w

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, FD&C Red 40, FD&C Yellow 5, Fragrance, Glycerin, Laurmine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium Glutamate Diacetate, Water

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of the reach of children

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Antibacterial skin cleanser Effective in destroying harful bacteria to prevent antibacterial cleansing", "Purpose": "Antibacterial", "Warnings": "For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Directions": "Read entire label before using this product. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds and rinse with clean water.", "Active ingredient": "Benzalkonium Chloride 0.13% w/w", "Inactive Ingredients": "Aloe Barbadensis Leaf Juice, Citric Acid, FD&C Red 40, FD&C Yellow 5, Fragrance, Glycerin, Laurmine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium Glutamate Diacetate, Water", "Keep out of reach of children": "Keep out of the reach of children"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:23.901132 · Updated: 2026-03-14T23:05:05.669082