Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9380bee7-7974-4b6a-b262-53ac09d97e0f
Route
TOPICAL
Published
Effective Date 2013-05-27
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
Description

Benzalkonium Chloride 0.115%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.115%

Uses

For handwashing to decrease bacteria on the skin

Section 50565-1

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

Warnings

For external use only

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

Active Ingredient

Benzalkonium Chloride 0.115%

Inactive Ingredients

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

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

Uses

For handwashing to decrease bacteria on the skin

Section 50565-1 (50565-1)

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

Purpose

Antibacterial

Warnings

For external use only

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.
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%

Inactive Ingredients

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

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: 2026-02-15T11:55:37.893144 · Updated: 2026-03-14T22:53:29.712463