PANAMA JACK BURN RELIEF GEL (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES INC.]

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  • PANAMA JACK BURN RELIEF GEL (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES INC.]

PANAMA JACK BURN RELIEF GEL (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES INC.]
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NDC 58443-0261-4
Set ID 7055acd5-1c83-397e-e053-2a91aa0a3852
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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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