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

Purpose

First Aid Antiseptic Topical Analgesic

Description

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


Medication Information

Warnings

For external use only.

Uses
  • Temporary relief of pain associated with minor cuts, scrapes, and 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
  • may be covered with a sterile bandage
Other Information
  • store at room temperature
  • tamper evident sealed packets
  • do not use any opened or torn packets
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

Description

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

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
Active Ingredients

Benzalkonium Chloride 0.13% w/w

Lidocaine HCl 0.5% w/w

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.com00-BUR-0011COM Rev. 00

NDC 55550-521-01


Structured Label Content

Warnings

For external use only.

Uses
  • Temporary relief of pain associated with minor cuts, scrapes, and 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
  • may be covered with a sterile bandage
Other Information
  • store at room temperature
  • tamper evident sealed packets
  • do not use any opened or torn packets
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

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
Active Ingredients

Benzalkonium Chloride 0.13% w/w

Lidocaine HCl 0.5% w/w

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.com00-BUR-0011COM Rev. 00

NDC 55550-521-01


Advanced Ingredient Data


Raw Label Data

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