SPL v2
SPL
SPL Set ID 0ac5d890-c262-4a30-9fd8-2de6cb0f7601
Route
TOPICAL
Published
Effective Date 2024-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (100 mg) Benzocaine (50 mg)
Inactive Ingredients
Isopropyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-14

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 relieve pain 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 a doctor if conditions persist or get worse.

Warnings

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

Directions
  • clean the affected area
  • apply a small amount of this product on the area 1 - 3 times daily
  • 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
Questions?

1-866-651-3660

Mon-Fri 8:00am-5:00pm EST

Manufactured for American Safety & First Aid Osceola, IN 48561

V1_11-7-19

Active Ingredient

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Other Information
  • store at room temperature
Inactive Ingredients

isopropyl alcohol, purified water

Principal Display Panel – Bottle Label

0681

NDC 73598-0681-1

Antiseptic

First Aid Antiseptic

For Temporary Pain Relief

and to Help Prevent

Infection in Minor Cuts,

Scrapes and Abrasions

American Safety

& First Aid

2 fl. Oz. (59.1 ml)


Structured Label Content

Uses

First aid to help prevent infection and relieve pain 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 a doctor if conditions persist or get worse.

Purpose

First aid antiseptic

Topical pain relief

Warnings

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

Directions
  • clean the affected area
  • apply a small amount of this product on the area 1 - 3 times daily
  • 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
Questions?

1-866-651-3660

Mon-Fri 8:00am-5:00pm EST

Manufactured for American Safety & First Aid Osceola, IN 48561

V1_11-7-19

Active Ingredient

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

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

isopropyl alcohol, purified water

Principal Display Panel – Bottle Label

0681

NDC 73598-0681-1

Antiseptic

First Aid Antiseptic

For Temporary Pain Relief

and to Help Prevent

Infection in Minor Cuts,

Scrapes and Abrasions

American Safety

& First Aid

2 fl. Oz. (59.1 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)