Be Smart Get Prepared Burn Cream
FDA Label NDC 55550-521

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Total Resources International, Inc for the product Be Smart Get Prepared Burn Cream (NDC 55550-521). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzalkonium Chloride 0.13% w/w

Lidocaine HCl 0.5% w/w

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

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

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, or serious burns
  • for more than one week unless directed by a doctor

Keep Out Of Reach Of Children.

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

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

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

Principal Display Panel – 0.90ml Pouch Label (Bex03 0000 01)

Principal Display Panel – 0.90ml Pouch Label (Bex03 0000 01)

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