POMODA DRAGON PAIN NUMBING CREAM [SIGAN INDUSTRIES GROUP]

POMODA DRAGON PAIN NUMBING CREAM [SIGAN INDUSTRIES GROUP]
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NDC 65365-284-01, 65365-284-06
Set ID 56ef22ac-4226-0970-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager SIGAN INDUSTRIES GROUP
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • 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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