Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID eacb5138-4af8-4550-b883-5603ad96ed7d
Route
TOPICAL
Published
Effective Date 2024-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g) Lidocaine (0.5 g)
Inactive Ingredients
Aloe Vera Leaf Cetostearyl Alcohol Glycerin Water Edetate Disodium Anhydrous Ethylhexylglycerin Glyceryl Stearate/peg-100 Stearate Maltodextrin Phenoxyethanol Propylene Glycol Stearic Acid Mineral Oil Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-16
Description

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

Uses
  • Temporary relief of pain associated with minor cuts, scrapes, and burns.
  • Helps protect against harmful bacteria.
Warnings

For external use only.

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Do Not Use
  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Other Information
  • store at room temperature
  • tamper evident sealed packets
  • do not use any opened or torn packets
Active Ingredients

Benzalkonium Chloride 0.13% w/w

Lidocaine HCl 0.5% w/w

Inactive Ingredients

aloe barbadensis leaf juice, cetearyl alcohol, disodium edta, ethylhexylglycerin, glycerin, glyceryl stearate/peg-100 stearate, maltodextrin, mineral oil, phenoxyethanol, propylene glycol, stearic acid, sodium hydroxide, water

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center directly.

Principal Display Panel – 0.90ml Pouch Label

BE SMART

GET PREPARED®

BURN CREAM

0.03 oz [0.90 g]

Single Use

Made in China

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.besmartgetprepared.com • 00-BUR-0011COM Rev. 00

NDC 55550-521-01

Structured Label Content

Uses
  • Temporary relief of pain associated with minor cuts, scrapes, and burns.
  • Helps protect against harmful bacteria.
Purpose

First Aid Antiseptic

Topical Analgesic

Warnings

For external use only.

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Do Not Use (Do not use)
  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Other Information
  • store at room temperature
  • tamper evident sealed packets
  • do not use any opened or torn packets
Active Ingredients

Benzalkonium Chloride 0.13% w/w

Lidocaine HCl 0.5% w/w

Inactive Ingredients

aloe barbadensis leaf juice, cetearyl alcohol, disodium edta, ethylhexylglycerin, glycerin, glyceryl stearate/peg-100 stearate, maltodextrin, mineral oil, phenoxyethanol, propylene glycol, stearic acid, sodium hydroxide, water

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

If swallowed, get medical help or contact a Poison Control Center directly.

Principal Display Panel – 0.90ml Pouch Label (Principal Display Panel – 0.90mL Pouch Label)

BE SMART

GET PREPARED®

BURN CREAM

0.03 oz [0.90 g]

Single Use

Made in China

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.besmartgetprepared.com • 00-BUR-0011COM Rev. 00

NDC 55550-521-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:26.676677 · Updated: 2026-03-14T23:03:31.233369