Label: BURN RELIEF EXTRA STRENGTH KOOL-DOWN- lidocaine - 3.9% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 16, 2019

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  • Active ingredient

    Lidocaine - 3.9%

  • Purpose

    Topical Pain Reliever

  • Keep Out of Reach of Children

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

  • Uses

    Temporarily relieves pain due to:

    • burns
    • insect bites
    • 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
    • symptoms last more than 7 days or clear up and occur again within a few days.

  • Directions

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

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice

    Glycerin

    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

    Canola Oil

    Fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF EXTRA STRENGTH  KOOL-DOWN
    lidocaine - 3.9% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61566-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE3.9 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)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61566-117-04113 g in 1 BOTTLE; Type 0: Not a Combination Product04/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/15/2013
    Labeler - Kool-Down Inc (146580548)
    Registrant - CGI Packaging, LLC (080691099)
    Establishment
    NameAddressID/FEIBusiness Operations
    CGI Packaging, LLC080691099manufacture(61566-117)
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