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
Purpose

First aid antiseptic Topical analgesic

Description

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

Medication Information

Warnings

For external use only

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

First aid antiseptic Topical analgesic

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

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

Description

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

Purposes

First aid antiseptic

Topical analgesic

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

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

Warnings

For external use only

Uses
  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria
Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • children under 2: consult a doctor
Inactive Ingredients

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

Purposes

First aid antiseptic

Topical analgesic

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

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

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