First Aid Burn Cream
FDA Label NDC 70897-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Davemed Healthcare Co., Ltd for the product First Aid Burn Cream (NDC 70897-001). 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, keep out of reach of children, do not use, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Active Ingredient

Lidocaine HCL 0.5%

Benzalkonium Chloride 0.13%

Purpose

First aid antiseptic, external analgesic

Temporary relief of pain associated with minor burns

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns.

Keep Out Of Reach Of Children

If ingested, get medical help or contact a Poison Control Center right away.

Do Not Use

DO NOT USE:

  • in eyes
  • in large quantities
  • over raw blistered areas or on deep punctured wounds, animal bites or serious burns
  • for more than one week

Directions

  • Clean affected area
  • apply small amount not more than 3 times daily
  • maybe covered with a sterile bondage

Inactive Ingredients

inactive ingredient

Other Information

Other Information

Store at room temperature

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