Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0f6d3ee2-9106-43f9-957a-c1cce4c38ad1
Route
TOPICAL
Published
Effective Date 2013-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 g) Benzocaine (46 g)
Inactive Ingredients
Isopropyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-07-25

Description

Benzalkonium Chloride 0.1% Benzocaine 5.0%

Purpose

First aid antiseptic Topical pain relief


Medication Information

Purpose

First aid antiseptic

Topical pain relief

Description

Benzalkonium Chloride 0.1% Benzocaine 5.0%

Uses

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if condition persists or gets worse

Warnings

For external use only. Flammable keep away from fire or flame

Directions
  • clean affected area and spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 ask a doctor
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 Ingredients

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Inactive Ingredients

isopropyl alcohol, purified water

Principal Display Panel – 2 Fl. Oz Packet Label

The Provision

First Aid

Line™

Antiseptic Spray

For Temporary Pain

Relief and to Help

Prevent Infection in

Minor Cuts, Scrapes

and Abrasions.

2 fl. oz. (59.1 ml)

Reorder no. 3501


Structured Label Content

Uses

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition persists or gets worse

Purpose

First aid antiseptic

Topical pain relief

Warnings

For external use only. Flammable keep away from fire or flame

Directions
  • clean affected area and spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 ask a doctor
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 Ingredients

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Inactive Ingredients

isopropyl alcohol, purified water

Principal Display Panel – 2 Fl. Oz Packet Label (Principal Display Panel – 2 fl. oz Packet Label)

The Provision

First Aid

Line™

Antiseptic Spray

For Temporary Pain

Relief and to Help

Prevent Infection in

Minor Cuts, Scrapes

and Abrasions.

2 fl. oz. (59.1 ml)

Reorder no. 3501


Advanced Ingredient Data


Raw Label Data

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