SPL v1
SPL
SPL Set ID 7852db3a-c0ed-4976-ab63-de32fe17d25e
Route
TOPICAL
Published
Effective Date 2020-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Propylene Glycol Triethylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-03
Description

Benzalkonium Chloride 0.13%

Medication Information

Description

Benzalkonium Chloride 0.13%

Uses
  • Helps reduce bacteria on the skin.
  • Recommended for repeated use.
Section 50565-1

Keep out of reach of children.

Section 55105-1

Warnings
  • For external use only.
  • Avoid contact with eyes.
  • In case of contact, flush thoroughly with water.
Directions

Apply product to hands and rub until dry.

Product Label

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Store in cool dry place between 35° and 103°F.

Inactive Ingredients

Deionized Water, Propylene Glycol, Triethylene Glycol, Phospholipids Complex, Organo Silane Quaternaries.

Structured Label Content

Uses
  • Helps reduce bacteria on the skin.
  • Recommended for repeated use.
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55105-1 (55105-1)

Warnings
  • For external use only.
  • Avoid contact with eyes.
  • In case of contact, flush thoroughly with water.
Directions

Apply product to hands and rub until dry.

Product Label

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information (Other information)

Store in cool dry place between 35° and 103°F.

Inactive Ingredients (Inactive ingredients)

Deionized Water, Propylene Glycol, Triethylene Glycol, Phospholipids Complex, Organo Silane Quaternaries.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:00.769517 · Updated: 2026-03-14T22:57:20.173282