Label: BURNAID BURN GEL- tea tree oil gel

  • 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

Drug Label Information

Updated 03/14

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Meleleuca Oil 10mg/g

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  • PURPOSE

    Purpose

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

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  • 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.
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  • Inactive ingredients

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

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  • 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.

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  • 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
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  • INGREDIENTS AND APPEARANCE
    BURNAID BURN GEL 
    tea tree oil gel
    Product Information
    Product Type HUMAN OTC DRUG 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 (UNII: VIF565UC2G) (Tea Tree Oil - UNII:VIF565UC2G) Tea Tree Oil 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    PEG-7 Glyceryl Cocoate (UNII: VNX7251543)  
    Trolamine (UNII: 9O3K93S3TK)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Lactic Acid (UNII: 33X04XA5AT)  
    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)
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