SPL v1
SPL
SPL Set ID ac857276-8d7b-2f62-e053-2a95a90a3376
Route
TOPICAL
Published
Effective Date 2020-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Polysorbate 20 Propylene Glycol Alpha-tocopherol Acetate Water Aloe Vera Leaf Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-30
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

• Keep containers tightly closed in a dry, cool and well-ventilated place.

• Recommended storage temperature: 32°F to 104°F (0°C to 40°C)

Inactive Ingredients

Aloe barbadensis leaf juice, fragrance, phenoxyethanol, polysorbate 20, propylene glycol, tocopheryl acetate, water

When Using This Product

When using this product

  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin
Stop Use and As A Doctor If

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours.
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.

Package Label/principal Display

NDC 79650-004-01, 320 mL

Structured Label Content

Uses

To decrease bacteria on the skin that could cause disease.

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

• Keep containers tightly closed in a dry, cool and well-ventilated place.

• Recommended storage temperature: 32°F to 104°F (0°C to 40°C)

Inactive Ingredients

Aloe barbadensis leaf juice, fragrance, phenoxyethanol, polysorbate 20, propylene glycol, tocopheryl acetate, water

When Using This Product (When using this product)

When using this product

  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin
Stop Use and As A Doctor If (Stop use and as a doctor if)

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours.
Keep Out of Reach of Children (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.

Package Label/principal Display (Package Label/Principal Display)

NDC 79650-004-01, 320 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:26.981044 · Updated: 2026-03-14T22:58:00.033401