Label: DRAGON PAIN NUMBING ROLL-ON- lidocaine hydrochloride liquid

  • 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 July 26, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine HCl 4%

  • Purpose

    Topical analgesic

  • Use

    • For the temporary relief of pain
  • Warnings

    For external use only

    Do not use

    • on large areas of the body, particularly over raw surfaces or blistered areas
    • on wounds or damaged skin

    When using this product

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

    Stop use and ask a doctor if

    • condition worsens 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 StearateSE, Phenoxyethanol, Steareth-21, Water

  • Questions or comments?

    Call toll free 1-877-994-3666

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 71 g Container Carton

    POMADA
    DRAGON®

    Lidocaine HCl 4%

    PAIN NUMBING ROLL ON

    MAX STRENGTH

    NUMBS PAIN
    FAST

    HOURS OF
    RELIEF

    ODOR
    FREE

    KEEPS HANDS CLEAN!

    BLOCKS PAIN
    RECEPTORS

    NO MESS
    APPLICATOR!

    NET WT 2.5 oz (71 g)

    PRINCIPAL DISPLAY PANEL - 71 g Container Carton
  • INGREDIENTS AND APPEARANCE
    DRAGON PAIN NUMBING ROLL-ON 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-411
    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
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ceteth-20 phosphate (UNII: 921FTA1500)  
    Steareth-21 (UNII: 53J3F32P58)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-411-021 in 1 CARTON07/24/2021
    171 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/24/2021
    Labeler - Genomma Lab USA (832323534)
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