SPL v3
SPL
SPL Set ID 133bb055-551b-426f-8a4a-6ce1ee2dd479
Route
TOPICAL
Published
Effective Date 2013-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.2478 g)
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-05-02

Description

Drug Facts

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Drug Facts

Uses
  • First aid to help prevent infection in minor cuts, scrapes and burns
Section 42229-5

Drug Facts

Section 44425-7

Store at room temperature

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Warnings

For external use only

Directions
  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
Do Not Use
  • in the eyes, or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • shake well
  • store at room temperature
Inactive Ingredients

purified water, alcohol

Questions Or Comments?

1-800-327-2704

Manufactured for: Respond Industries and American First Aid

Mason, OH 45040

#61025

Rev 04/13

Stop Use and Ask A Doctor If
  • condition persists or gets worse
Ask A Doctor Before Use If You Have
  • deep or puncture wounds, animal bites or serious burns
Principal Display Panel – Bottle Label

Antiseptic

Spray

FIRST AID ANTISEPTIC



Convenient pump

spray allows no-touch

application. Use as a

first aid treatment to

help prevent infection

in cuts and scrapes.



2 fl. oz. (59.1 mL)


Structured Label Content

Uses
  • First aid to help prevent infection in minor cuts, scrapes and burns
Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Store at room temperature

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Purpose

First Aid Antiseptic

Warnings

For external use only

Directions
  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
Do Not Use (Do not use)
  • in the eyes, or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information (Other information)
  • shake well
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

purified water, alcohol

Questions Or Comments? (Questions or comments?)

1-800-327-2704

Manufactured for: Respond Industries and American First Aid

Mason, OH 45040

#61025

Rev 04/13

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition persists or gets worse
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds, animal bites or serious burns
Principal Display Panel – Bottle Label (PRINCIPAL DISPLAY PANEL – bottle label)

Antiseptic

Spray

FIRST AID ANTISEPTIC



Convenient pump

spray allows no-touch

application. Use as a

first aid treatment to

help prevent infection

in cuts and scrapes.



2 fl. oz. (59.1 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)