Burn Cream
FDA Label NDC 55550-902

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 for the product Burn Cream (NDC 55550-902). 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 other, active ingredients, purpose, uses, warnings, do not use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Benzalkonium

Chloride 0.13% w/w

Lidocaine

HCI 0.5% w/w

Purpose

First Aid

Antiseptic

Topical

Analgesic

Uses

  • temporary relief of pain associated with minor 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, serious burns
  • for more than one week unless directed by a doctor

Otc - Keep Out Of Reach Of Children

Keep out of reach of children If ingested contact a Poison Control Center right away

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

Principal Display Panel – Pouch Label

BE SMART

GET PREPARED

BURN
CREAM
W/ ALOE VERA • FOR MINOR BURNS

0.03 oz [0.90 g]

SINGLE USE

Made in USA • Mfd. for: TOTAL RESOURCES INTL.
Walnut, California 91789

00-BUR-0009 Rev.01 • NDC #55550-902-21

Figure (Tot08 0000 01)

Figure (Tot08 0000 01)

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