Label: PANAMA JACK BURN RELIEF GEL WITH LIDOCAINE- lidocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 17, 2020

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  • Active Ingredients

    Lidocaine Hydrochloride (0.72%)

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of pain associated with sunburn, insect bites, and minor skin irritations.

  • WARNINGS

    For external use only.

    When using this product

    • Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas.

    Stop use and contact a physician

    • If irritation occurs.
    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

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

  • 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: ask a doctor
  • Other Information

    • Protect from heat,
    • Store at controlled room temperature.
  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5

  • Questions or Comments?

    Email us at info@panamajack.com or call 1-800-840-5225

  • Panama Jack Burn Relief with Lidocaine

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  BURN RELIEF GEL WITH LIDOCAINE
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS7.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0204-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/19/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/19/2015
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0204) , manufacture(58443-0204) , label(58443-0204)
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