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

Purpose

First aid antiseptic Topical pain relief

Description

Benzalkonium Chloride 0.1% Benzocaine 5.0%


Medication Information

Warnings

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

Uses

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

Purpose

First aid antiseptic

Topical pain relief

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

isopropyl alcohol, purified water

Description

Benzalkonium Chloride 0.1% Benzocaine 5.0%

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

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%

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

Warnings

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

Uses

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

Purpose

First aid antiseptic

Topical pain relief

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

isopropyl alcohol, purified water

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

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%

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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