SPL v4
SPL
SPL Set ID 3eb119d8-59da-405c-a5f4-a025636d394a
Route
TOPICAL
Published
Effective Date 2019-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg) Benzocaine (50 mg)
Inactive Ingredients
Isopropyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-07-09
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

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 – Bottle Label

First Aid

Antiseptic

Spray

Aids in Preventing Infections

Temporary Pain Relief

Fights Infection

Promotes Healing

#623 2 Fl. Oz. (59 mL)

Mfd. For

Afassco

MINDEN, NV 89423

res

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

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 (Inactive ingredients)

isopropyl alcohol, purified water

Principal Display Panel – Bottle Label (PRINCIPAL DISPLAY PANEL – bottle label)

First Aid

Antiseptic

Spray

Aids in Preventing Infections

Temporary Pain Relief

Fights Infection

Promotes Healing

#623 2 Fl. Oz. (59 mL)

Mfd. For

Afassco

MINDEN, NV 89423

res

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:28.851708 · Updated: 2026-03-14T23:00:56.097890