Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b971cc41-fe23-4be3-9564-e46d55df1d68
Route
TOPICAL
Published
Effective Date 2025-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-14
Description

Benzalkonium Chloride 0.13% w/w Lidocaine HCI 0.5% w/w

Purpose

First aid antiseptic Topical analgesic

Medication Information

Purpose

First aid antiseptic Topical analgesic

Description

Benzalkonium Chloride 0.13% w/w Lidocaine HCI 0.5% w/w

Uses
  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria
Purposes

First aid antiseptic

Topical analgesic

Warnings

For external use only

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • children under 2: consult a doctor
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
Active Ingredients

Benzalkonium Chloride 0.13% w/w

Lidocaine HCI 0.5% w/w

Inactive Ingredients

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

Keep Out of Reach of Children

If ingested contact a Poison Control Center right away.

Principal Display Panel – 0.03 Oz Pouch Label

BE SMART

GET PREPARED®

BURN CREAM

0.03 oz [0.90 g]

Single Use

Made in USA

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.besmartgetprepared.com • 00-BUR-0009 Rev. 03

NDC 55550-902-21

Structured Label Content

Uses
  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria
Purposes

First aid antiseptic

Topical analgesic

Warnings

For external use only

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • children under 2: consult a doctor
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
Active Ingredients

Benzalkonium Chloride 0.13% w/w

Lidocaine HCI 0.5% w/w

Inactive Ingredients

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

Keep Out of Reach of Children (Keep out of reach of children)

If ingested contact a Poison Control Center right away.

Principal Display Panel – 0.03 Oz Pouch Label (Principal Display Panel – 0.03 oz Pouch Label)

BE SMART

GET PREPARED®

BURN CREAM

0.03 oz [0.90 g]

Single Use

Made in USA

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.besmartgetprepared.com • 00-BUR-0009 Rev. 03

NDC 55550-902-21

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:04.140255 · Updated: 2026-03-14T23:08:35.242045