SPL v1
SPL
SPL Set ID 9fa378a0-afb5-4a98-88d0-e4512296f446
Route
TOPICAL
Published
Effective Date 2012-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg) Lidocaine (5 mg)
Inactive Ingredients
Aloe Vera Leaf Alcohol Methylparaben Mineral Oil Paraffin Propylparaben Water Petrolatum White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-01-27
Description

Drug Facts

Purpose

First Aid Antiseptic Topical analgesic

Medication Information

Purpose

First Aid Antiseptic

Topical analgesic

Description

Drug Facts

Uses
  • for the temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria
Section 42229-5

Drug Facts

Warnings

For external use only

Do Not Use
  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor
Questions?

1-800-275-3433

Other Information
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets
Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Stop Use and Ask A Doctor If
  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

If ingested, get medical help or contact a Poison Control Center right away.

Principal Display Panel – Pac Kit 12 Count Box

PAC-KIT

FIRST AID

First Aid

Burn Cream

Packets

Paquetes de crema

para quemaduras

12 First Aid Burn

Cream Packets,

0.9gm ea.

12 paquetes,

0,9 gm cada uno.

Reorder #13-006

ANSI Z308. 1-2009

Structured Label Content

Uses
  • for the temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria
Section 42229-5 (42229-5)

Drug Facts

Purpose

First Aid Antiseptic

Topical analgesic

Warnings

For external use only

Do Not Use (Do not use)
  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor
Questions?

1-800-275-3433

Other Information (Other information)
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets
Active Ingredients (Active ingredients)

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients (Inactive ingredients)

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If ingested, get medical help or contact a Poison Control Center right away.

Principal Display Panel – Pac Kit 12 Count Box (PRINCIPAL DISPLAY PANEL – Pac-Kit 12 count box)

PAC-KIT

FIRST AID

First Aid

Burn Cream

Packets

Paquetes de crema

para quemaduras

12 First Aid Burn

Cream Packets,

0.9gm ea.

12 paquetes,

0,9 gm cada uno.

Reorder #13-006

ANSI Z308. 1-2009

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:28.572764 · Updated: 2026-03-14T22:53:08.969860