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Unburn (Water-Jel Technologies)

Available Formats

Dosage Form Package Information Links
GEL 240 mL in 1 BOTTLE, PLASTIC (59898-500-14) Label Information
GEL 59 mL in 1 BOTTLE, PLASTIC (59898-500-10) Label Information

Complete Unburn Information

  • Active ingredient

    Lidocaine HCl 2.5%


  • Purpose

    External analgesic


  • Uses

    for the temporary relief of pain associated with:

    • sunburn
    • minor burns
    • minor skin irritations
    • insect bites

  • Warnings

    For external use only

    Do not use
    • in large quantities, particularly over raw surfaces or blistered areas

    When using this product
    • avoid contact with eyes

    Stop use and ask a doctor if
    • condition worsens
    • symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days

    Keep out of the reach of children

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


  • Directions

    • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor

  • Other information

    • store at 15 o to 25 oC (59 o to 77 oF)
    • do not freeze
    • you may report a serious adverse reaction to this product to 1-800-275-3433

  • Inactive ingredients

    acrylates/C20-30 alkyl acrylate crosspolymer, aloe, carbomer, diazolidnyl urea, edetate disodium, glyceryl-7 stearate, methylparaben, octoxynol-9, polysorbate 20, propylene glycol, propylparaben, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate


  • QUESTIONS

    1-800-275-3433

    Monday - Friday (9a.m. - 5 p.m. EST)

    www.unburn.info


  • Principle Display Panel

    Unburn


  • INGREDIENTS AND APPEARANCE
    UNBURN 
    lidocaine hydrochloride gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59898-500
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59898-500-10 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/17/2013
    2 NDC:59898-500-14 240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/17/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/17/2013
    Labeler - Water-Jel Technologies (155522589)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(59898-500)