SPL v20
SPL
SPL Set ID 1c6650c9-29fa-4fba-8442-fe294a2087c0
Route
TOPICAL
Published
Effective Date 2019-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.05 g)
Inactive Ingredients
Propylene Glycol Polysorbate 20 Water Dipropylene Glycol Ethylhexylglycerin Chlorphenesin Bronopol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-12-04
Description

DRUG FACTS

Purpose

Antiseptic

Medication Information

Warnings and Precautions

For external use only.

Purpose

Antiseptic

Description

DRUG FACTS

Uses:

Antiseptic cleansing of hands to decrease bacteria on skin without the use of soap and water.

Section 42229-5

DRUG FACTS

Section 50570-1
  • for external use only.
  • do not use in eyes. If this occurs, rinse thoroughly with water.
  • Stop use and ask a doctor if irritation o redness develops and persists for more than 72 hours.
Section 51945-4

Directions

Tear open packedt, unfold and use as wash cloth. Allow hands to dry without wiping.

Active Ingredient

BENZALKONIUM CHLORIDE  ..........  0.05%

Inactive Ingredients:

Water, Propylene glycol, Polysorbate 20, Dipropylene glycol, Ethylhexylglycerin, Chlorphenesin, Bronopol, Citric acid.

Keep Out of Reach of Children.

if swallowed get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses:

Antiseptic cleansing of hands to decrease bacteria on skin without the use of soap and water.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)
  • for external use only.
  • do not use in eyes. If this occurs, rinse thoroughly with water.
  • Stop use and ask a doctor if irritation o redness develops and persists for more than 72 hours.
Section 51945-4 (51945-4)

Purpose

Antiseptic

Directions

Tear open packedt, unfold and use as wash cloth. Allow hands to dry without wiping.

Active Ingredient

BENZALKONIUM CHLORIDE  ..........  0.05%

Inactive Ingredients:

Water, Propylene glycol, Polysorbate 20, Dipropylene glycol, Ethylhexylglycerin, Chlorphenesin, Bronopol, Citric acid.

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:21.406260 · Updated: 2026-03-14T23:01:50.647319