Label: BURNAID BURN GEL- tea tree oil gel 

  • Label RSS
  • NDC Code(s): 51121-035-04, 51121-035-12
  • Packager: Clear Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Meleleuca Oil 10mg/g

    Close
  • PURPOSE

    Purpose

    For the first aid treatment of minor burns, scalds and sunburn.

    Close
  • Warning

    • Do not use on serious burns.

    • FOR EXTERNAL USE ONLY.

    • Discontinue use if irritation occurs.

    • Do not store at extreme temperatures.

    • Keep out of reach of children. If
    • swallowed, get medical help or contact a Poison Control Center right away.
    Close
  • Inactive ingredients

    Purified Water, Propylene Glycol, PEG 7 Glyceryl Cocoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Lactic Acid, Parabens

    Close
  • Directions

    Figure

    1. Tear open sachet. 2. Apply gel liberally to affected area. Do not rub in. 3. Cover if necessary.

    4. Seek medical attention if pain persists.

    Close
  • PRINCIPAL DISPLAY PANEL - 3.5 g Packet Label

    NDC 51121-035-12

    Burnaid®
    BURN GEL

    For first aid use on minor
    burns, scalds and sunburn

    • Cools
    • Soothes

    1/8 OZ. (3.5g)

    SINGLE USE ONLY. DISCARD AFTER USE.
    IF PACK HAS BEEN DAMAGED DO NOT USE.

    Principal Display Panel - 3.5 g Packet Label
    Close
  • INGREDIENTS AND APPEARANCE
    BURNAID BURN GEL 
    tea tree oil gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51121-035
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Tea Tree Oil (Tea Tree Oil) Tea Tree Oil 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Propylene Glycol  
    PEG-7 Glyceryl Cocoate  
    Trolamine  
    .Alpha.-Tocopherol Acetate  
    Lactic Acid  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51121-035-12 3.5 g in 1 PACKET
    2 NDC:51121-035-04 115 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 11/04/2013
    Labeler - Clear Healthcare LLC (078886273)
    Close