Label: PANAMA JACK BURN RELIEF GEL- lidocaine hydrochloride gel

  • 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 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

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if rash occurs

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

  • 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 occures.
    • 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 Ingredients

    Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Menthol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Sodium Hydroxide, Yellow 5, Water

  • Panama Jack Burn Relief Topical Analgesic Gel

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  BURN RELIEF GEL
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0261
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS7.128 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0261-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/25/2018
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0261) , manufacture(58443-0261) , label(58443-0261) , analysis(58443-0261)
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