Label: DRAGON PAIN NUMBING TOPICAL ANALGESIC- lidocaine hydrochloride cream

  • 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 February 21, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    POMADA
    DRAGON®

    LIDOCAINE HCl 4%
    MAX STRENGTH

    PAIN NUMBING CREAM

    BLOCKS PAIN RECEPTORS

    Numbs pain fast

    Hours of relief

    Odor free

    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
    Sigan Industries INC255106239MANUFACTURE(50066-056) , LABEL(50066-056) , PACK(50066-056)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!