SPL v2
SPL
SPL Set ID 673646aa-906c-424a-a2f4-07048160c5dc
Route
TOPICAL
Published
Effective Date 2014-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.96 g) Benzocaine (58.5 g)
Inactive Ingredients
Isopropyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-08-13

Description

Drug Facts

Purpose

First Aid Antiseptic Topical Pain Relief


Medication Information

Purpose

First Aid Antiseptic

Topical Pain Relief

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

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 doctor if condition persists or gets worse

Section 51945-4

First Aid Antiseptic

Temporary pain relief. Helps prevent infection in minor cuts, scrapes and abrasions.

M5081

3 fl. oz (88.7 ml.)

----------

FIRST AID ONLY

Distributed by First Aid Only, Inc

Vancouver, WA 96882 USA

Warnings

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

Directions
  • clean affected and spray
  • spray over the area 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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

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 doctor if condition persists or gets worse

Section 51945-4 (51945-4)

First Aid Antiseptic

Temporary pain relief. Helps prevent infection in minor cuts, scrapes and abrasions.

M5081

3 fl. oz (88.7 ml.)

----------

FIRST AID ONLY

Distributed by First Aid Only, Inc

Vancouver, WA 96882 USA

Purpose

First Aid Antiseptic

Topical Pain Relief

Warnings

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

Directions
  • clean affected and spray
  • spray over the area 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 (Inactive ingredients)

isopropyl alcohol, purified water


Advanced Ingredient Data


Raw Label Data

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