Label: BURN RELIEF PROFESSIONAL BIO-KOOL- lidocaine - 4% cream

  • NDC Code(s): 61566-201-04, 61566-201-14
  • Packager: Kool-Down Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 27, 2025

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  • ACTIVE INGREDIENT

    Lidocaine - 4.0%

  • PURPOSE

    Topical Pain Reliever

  • Uses

    Temporarily relieves pain due to: sunburns, burns, insect bites, and itching.

  • WARNINGS

    For external use only.

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

    When using this product keep out of eyes, use only as directed

    Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Adults and children 5 years of age and older: apply to affected area, not more than 3-4 times daily. Children under 5 years of age: ask a doctor.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Glycerol, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    labelimage description

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF PROFESSIONAL  BIO-KOOL
    lidocaine - 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61566-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61566-201-04113 g in 1 BOTTLE; Type 0: Not a Combination Product01/15/2013
    2NDC:61566-201-14128 g in 1 JAR; Type 0: Not a Combination Product06/23/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/15/2013
    Labeler - Kool-Down Inc. (146580548)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derrma Care Research Labs116817470manufacture(61566-201)
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