Label: POMODA DRAGON PAIN NUMBING 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 July 31, 2017

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  • ACTIVE INGREDIENT

    LIDOCAINE HCI 4%

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    FOR 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

  • QUESTION SOR COMMENTS?

    CALL TOLL FREE 1 877 99 GENOM (43666)

  • INACTIVE INGREDIENTS

    ACRYLATES/C10-30 ALKYL CRYLATE CROSSPOLYMER, ALCOHOL DENAT., AMINOMETHYL PROPANOL, C30-45 ALKYL CETEARLYL DIMETHICONE CROSSPOLYMER, CAPRYLYL METHICONE, CETEARYL ALCOHOL, CETETH-20 PHOSPHATE, DECOLORIZED ALOE BARBADENSIS LEAF JUICE, DICETYL PHOSPHATE DIMETHICONE, DISODIUM EDTA, ETHYLHEXYGLYCERIN, GLYCERYL STARATE SE, PHENOXYETHANOL, PURIFIED WATER, STEARETH-21

  • PACKAGE LABEL DISPLAY PANEL

    NEW MAX STRENGTH LIDOCAINE 4%

    POMADA DRAGON PAIN NUMBING CREAM

    CREMA PARA ANESTESIAR EL DOLOR LIDOCAINA HCI 4%

    ORDOR FREE. NO IRRITATION, NO BURNING./ SIN OLOR. SIN IRRITACIÓ​N. SIN ARDOR

    BLOCKS PAIN RECEPTORS/ BLOQUEA LOS RECEPTORES DEL DOLOR

    NET WT 2.7 OZ (76.5g)

    284-06284-01

  • INGREDIENTS AND APPEARANCE
    POMODA DRAGON PAIN NUMBING 
    pomoda dragon pain numbing cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65365-284
    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
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    STEARETH-21 (UNII: 53J3F32P58)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65365-284-061 in 1 CARTON08/16/2017
    1NDC:65365-284-0176.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/16/2017
    Labeler - SIGAN INDUSTRIES GROUP (251829404)
    Registrant - SIGAN INDUSTRIES INC (255106239)
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