DRAGON PAIN NUMBING TOPICAL ANALGESIC (LIDOCAINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA INC.]

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  • DRAGON PAIN NUMBING TOPICAL ANALGESIC (LIDOCAINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA INC.]

DRAGON PAIN NUMBING TOPICAL ANALGESIC (LIDOCAINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA INC.]
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NDC 50066-056-01
Set ID dbd5dc3e-206e-4c3f-b675-266f43a60e11
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine HCl 4%

  • Purpose

    Topical analgesic

  • Uses

    for the temporary relief of pain

  • Warnings

    For external use only

    Do not use

    ◆
    on large areas of the body or on raw or blistered skin
    ◆
    on wounds or damaged skin

    When using this product

    ◆
    use only as directed
    ◆
    do not use in large quantities
    ◆
    avoid contact with eyes
    ◆
    do not apply tight bandages
    ◆
    do not apply a heating pad to treated skin

    Stop use and ask a doctor if

    ◆
    conditions worsen or symptoms persist for more than 7 days
    ◆
    symptoms clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children to avoid accidental ingestion.

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

  • Directions

    ◆
    use only as directed Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 12 years of age: ask a doctor
  • Other information

    ◆
    Store at room temperature
    ◆
    Close cap tightly after use
  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol denat., Aminomethyl propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Decolorized Aloe barbadensis leaf juice, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearare SE, Phenoxyethanol, Steareth-21, Water

  • Questions or comments?

    Call toll free 1 877 99 GENOM (43666)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab USA, Inc.,
    Houston, TX 77027

  • PRINCIPAL DISPLAY PANEL - 76.5 g Bottle Carton

    NEW
    MAX STRENGTH
    LIDOCAINE 4%

    POMADA
    DRAGON®
    PAIN NUMBING CREAM

    Odor Free • No Irritation • No Burning

    BLOCKS PAIN RECEPTORS

    NET WT
    2.7 oz (76.5 g)

    PRINCIPAL DISPLAY PANEL - 76.5 g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DRAGON PAIN NUMBING  TOPICAL ANALGESIC
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Ceteth-20 Phosphate (UNII: 921FTA1500)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Steareth-21 (UNII: 53J3F32P58)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-056-011 in 1 CARTON09/07/2017
    176.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/07/2017
    Labeler - Genomma Lab USA Inc. (832323534)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(50066-056)
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