ec872c41-1cf0-40df-a455-9e4a138b316b

SPL v1
SPL
SPL Set ID ec872c41-1cf0-40df-a455-9e4a138b316b
Route
topical
Published
Effective Date 2023-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
ethylhexylglycerin phenoxyethanol water propylene glycol didecyldimonium chloride fragrance lemon orc2001060 glycerin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2023-08-22
Purpose

Antiseptic

Description

Benzalkonium Chloride (0.13%)

Medication Information

Warnings
  • Flammable. Keep away from heat and flame.
  • For External use only.
  • Do not usein eyes. In case of contact, rinse thoroughly with water.
  • Stop use & ask doctorif rash/redness or irritation appears/develops and persist for more than 72 hours.
Purpose

Antiseptic

Directions
  • Slowly peel back label and use one wipe. Reseal, keep closed to prevent evaporation.
  • Thoroughly wipe hands, allow to dry out rinsing. 
  • Discard after single use.
Inactive Ingredients

Water, phenoxyethanol, ethylhexyl glycerin, didecyldimonium chloride, propylene glycol, glycerin, fragrance.

Description

Benzalkonium Chloride (0.13%)

Use

For hand-washing to decrease bacteria on skin

Section 50565-1

Keep out of reach of childrenexcept under adult supervision.If swallowed, get medical help or contact a Poison Control Center right away.

Product Label

Active Ingredient

Benzalkonium Chloride (0.13%)

Structured Label Content

Warnings
  • Flammable. Keep away from heat and flame.
  • For External use only.
  • Do not usein eyes. In case of contact, rinse thoroughly with water.
  • Stop use & ask doctorif rash/redness or irritation appears/develops and persist for more than 72 hours.
Purpose

Antiseptic

Directions
  • Slowly peel back label and use one wipe. Reseal, keep closed to prevent evaporation.
  • Thoroughly wipe hands, allow to dry out rinsing. 
  • Discard after single use.
Inactive Ingredients (Inactive ingredients)

Water, phenoxyethanol, ethylhexyl glycerin, didecyldimonium chloride, propylene glycol, glycerin, fragrance.

Use

For hand-washing to decrease bacteria on skin

Section 50565-1 (50565-1)

Keep out of reach of childrenexcept under adult supervision.If swallowed, get medical help or contact a Poison Control Center right away.

Product Label (Product label)

Active Ingredient

Benzalkonium Chloride (0.13%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:07.034030 · Updated: 2026-03-14T23:01:17.657881