SPL v2
SPL
SPL Set ID b00687db-df8e-4593-e053-2995a90a5954
Route
TOPICAL
Published
Effective Date 2020-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Polysorbate 20 Fragrance Lemon Orc2001060 Propylene Glycol Aloe Vera Leaf Water Phenoxyethanol Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-28
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.
Inactive Ingredients

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

When Using This Product

When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water.

Stop Use and Ask A Doctor If

Stop use and ask a doctor if irritation and redness develop and persist.

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 Panel

NDC 79650-016-60; 255 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.
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 avoid contact with the eyes. In case of contact, flush eyes thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if irritation and redness develop and persist.

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 Panel (Package Label/Principal Display Panel)

NDC 79650-016-60; 255 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:48.785769 · Updated: 2026-03-14T22:58:34.022816