f2b8c495-3f8c-48b0-953c-06e3bb847dcb

SPL v1
SPL
SPL Set ID f2b8c495-3f8c-48b0-953c-06e3bb847dcb
Route
topical
Published
Effective Date 2020-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 g)
Inactive Ingredients
glycerin water coconut oil sunflower oil rosemary

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-15
Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

When using this product

  • keep out of eyes
  • use in a well-ventilated area
  • discontinue use if irritation and redness develops
Uses
  • handwash to help reduce bacteria that potentially can cause disease
  • helps prevent cross contamination by hand contact
  • recommended for repeated use
Purpose

Antiseptic

Directions
  • wet hands and forearms
  • apply 5 ml or palmful of soap to hands and forearms
  • scrub thoroughly for 30 seconds
  • rinse and repeat

Other Information

  • store at room temperature
  • for Hospital and Professional Use Only
Inactive Ingredients

Purified Water and Castile Soap Glycerin

Description

Benzalkonium Chloride 0.13%

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Active Ingredient

Benzalkonium Chloride 0.13%

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only.

When using this product

  • keep out of eyes
  • use in a well-ventilated area
  • discontinue use if irritation and redness develops
Uses
  • handwash to help reduce bacteria that potentially can cause disease
  • helps prevent cross contamination by hand contact
  • recommended for repeated use
Purpose

Antiseptic

Directions
  • wet hands and forearms
  • apply 5 ml or palmful of soap to hands and forearms
  • scrub thoroughly for 30 seconds
  • rinse and repeat

Other Information

  • store at room temperature
  • for Hospital and Professional Use Only
Inactive Ingredients (Inactive ingredients)

Purified Water and Castile Soap Glycerin

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Active Ingredient

Benzalkonium Chloride 0.13%

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:41.690824 · Updated: 2026-03-14T22:56:56.523889