1. Home
  2. Labeler Index
  3. Epic Medical Supply Corp
  4. 82749-009
  5. Label Information: First Aid Burn

FDA Label for First Aid Burn

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. QUESTIONS?
    9. PRODUCT LABEL

First Aid Burn Product Label

The following document was submitted to the FDA by the labeler of this product Epic Medical Supply Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Product Label



image description - image 009

image description - image 009


* Please review the disclaimer below.