drug facts

drug facts
SPL v1
SPL
SPL Set ID dc6d06c9-2a5c-4c42-99f6-19318c0bf8db
Route
topical
Published
Effective Date 2013-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.115 g)
Inactive Ingredients
water aloe vera leaf disodium cocoamphodiacetate methylchloroisothiazolinone methylisothiazolinone .alpha.-tocopherol acetate edetate disodium citric acid monohydrate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-05-27
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.115%

Medication Information

Warnings

For external use only

Uses

For handwashing to decrease bacteria on the skin

Purpose

Antibacterial

Directions
  • Storage, Store at room temperature
  • Dispensing Remove seal band. Lift tab at front of lid. Pull up corner of center sheet and thread through dispenser slit in lid. Close lid to retain moisture.
  • Use. Apply wipe thoroughly to hands as desired. Allow to dry without rinsing.
  • Disposal. Dispose of used wipes in a trash receptacle after use. Do not flush.
Inactive Ingredients

Water, Aloe Barbadensis Leaf Extract, Disodium Cocoamphodiacetate, SD Alcohol 40-B, Methylchloroisothiazolinone, Methylisothiazolinone, Tocopheryl Acetate, Disodium EDTA, Citric Acid, Fragrance

Description

Benzalkonium Chloride 0.115%

Section 50565-1

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away.

Do Not Use
  • in the eyes
  • if you are allergic to any of the ingredients
Package Label

Active Ingredient

Benzalkonium Chloride 0.115%

When Using This Product

if eye contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If

if irritation and redness develops and persist for more than 72 hours.

Structured Label Content

Warnings

For external use only

Uses

For handwashing to decrease bacteria on the skin

Purpose

Antibacterial

Directions
  • Storage, Store at room temperature
  • Dispensing Remove seal band. Lift tab at front of lid. Pull up corner of center sheet and thread through dispenser slit in lid. Close lid to retain moisture.
  • Use. Apply wipe thoroughly to hands as desired. Allow to dry without rinsing.
  • Disposal. Dispose of used wipes in a trash receptacle after use. Do not flush.
Inactive Ingredients

Water, Aloe Barbadensis Leaf Extract, Disodium Cocoamphodiacetate, SD Alcohol 40-B, Methylchloroisothiazolinone, Methylisothiazolinone, Tocopheryl Acetate, Disodium EDTA, Citric Acid, Fragrance

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away.

Do Not Use (Do not use)
  • in the eyes
  • if you are allergic to any of the ingredients
Package Label

Active Ingredient

Benzalkonium Chloride 0.115%

When Using This Product (When using this product)

if eye contact occurs, rinse eyes thoroughly with water.

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

if irritation and redness develops and persist for more than 72 hours.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:38.679557 · Updated: 2026-03-14T22:53:30.775793