49314-0001-1 Unishield

49314-0001-1 Unishield
SPL v2
SPL
SPL Set ID f72851ba-bbdd-5533-e053-6294a90a8216
Route
TOPICAL
Published
Effective Date 2025-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-20

Description

Benzalkonium chloride 0.13%

Purpose

First aid antiseptic


Medication Information

Purpose

First aid antiseptic

Description

Benzalkonium chloride 0.13%

Uses

first aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Flammable keep away from fire or flame

Directions
  • clean affected area & spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • not to be used on children under 12 of years of age
Do Not Use
  • near eyes or mucous membranes
  • on deep or puncture wounds , animal bites, or serious burns
  • over large areas of the body
  • more than one week unless directed by a doctor
Active Ingredient

Benzalkonium chloride 0.13%

Inactive Ingredients

ethyl alcohol, purified water

Questions Or Comments?

1-800-480-5855

Stop Use and Ask A Doctor

if condition persists or gets worse

Keep Out of Reach of Children.

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

Package Label Principal Display Panel


Structured Label Content

Uses

first aid to help prevent infection in minor cuts, scrapes and burns

Purpose

First aid antiseptic

Warnings

For external use only

Flammable keep away from fire or flame

Directions
  • clean affected area & spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • not to be used on children under 12 of years of age
Do Not Use (Do not use)
  • near eyes or mucous membranes
  • on deep or puncture wounds , animal bites, or serious burns
  • over large areas of the body
  • more than one week unless directed by a doctor
Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Inactive Ingredients (Inactive ingredients)

ethyl alcohol, purified water

Questions Or Comments? (Questions or comments?)

1-800-480-5855

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

if condition persists or gets worse

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.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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