Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 788307ca-7e3a-9b29-e053-2a91aa0a8e6b
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
Alcohol 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

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 wiping.
  • 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.

Keep Out of Reach of Children

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

Structured Label Content

Uses

For handwashing to decrease bacteria on the skin

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 wiping.
  • 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 (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.

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: 2026-02-15T11:56:39.913100 · Updated: 2026-03-14T22:55:18.422436