First Aid Burn Cream
FDA Label NDC 87251-009

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 4 Visions Llc for the product First Aid Burn (NDC 87251-009). 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, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

Topical Analgesic

Topical Antiseptic

Uses

For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts
  • Scrapes

Warnings

For external use only


Do not use

  • in the eyes 
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns 
  • in large quantities, particularly over raw surfaces or blistered areas

    • Stop use and ask a doctor if 

    • the condition gets worse 
    • condition clears up and recurs within a few days 
    • condition persists for more than 7 days
      • If pregnant or breast feeding, ask a health care professional before use.
      • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 to 4 times daily may be covered with a sterile bandage
  • Children under 2 years: consult a doctor

Other Information

  • Store at room temperature 
  • tamper evident sealed packets 
  • do not use any opened or torn packets

Inactive Ingredients

Butylated Hydroxytoluene, Cetostearyl Alcohol, Dimethicone, Edetate Disodium, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Macrogol Cetostearyl Ether 20, Methylcellulose, Purified Water, Sodium Methylparaben, Sodium Propylparaben.

Questions?

Contact: 1.848.373.2075

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