Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f886b704-0a6a-4bc3-8bfd-d97996eb25d0
Route
TOPICAL
Published
Effective Date 2010-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.115 mL)
Inactive Ingredients
Water Aloe Vera Leaf Methylchloroisothiazolinone Methylisothiazolinone Edetate Disodium Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-10-01

Description

Benzalkonium chloride 0.115%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.115%

Uses
For hand washing to decrease bacteria on the skin
Warnings
For external use only



Directions
  • For use apply thoroughly to hands and face as desired. Allow to dry without wiping. Discard wipe in trash receptacle after use. Do not flush.

  • For dispensing tear open package at notch. Dispose of wrapper in trash. Do  not flush

Package Label
Package label







Active Ingredient

Benzalkonium chloride 0.115%

Other Information
May be used on face, arms and legs.

Inactive Ingredients
Acrylates Copolymer, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, FDC Yellow 5, FDC Blue 1, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Sodium Laureth Sulfate, Water

When Using This Product
avoid the eyes and mucous membranes

If contact occurs, rinse eyes thoroughly with water

Stop Use and Ask A Doctor If
if irritation develops and persists for more than 72 hours.

Keep Out of Reach of Children

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


Structured Label Content

Uses
For hand washing to decrease bacteria on the skin
Purpose

Antibacterial

Warnings
For external use only



Directions
  • For use apply thoroughly to hands and face as desired. Allow to dry without wiping. Discard wipe in trash receptacle after use. Do not flush.

  • For dispensing tear open package at notch. Dispose of wrapper in trash. Do  not flush

Package Label
Package label







Active Ingredient

Benzalkonium chloride 0.115%

Other Information
May be used on face, arms and legs.

Inactive Ingredients
Acrylates Copolymer, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, FDC Yellow 5, FDC Blue 1, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Sodium Laureth Sulfate, Water

When Using This Product (When using this product)
avoid the eyes and mucous membranes

If contact occurs, rinse eyes thoroughly with water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
if irritation develops and persists for more than 72 hours.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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