PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]

PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]
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NDC 55992-404-11
Set ID 9d2654e4-ca94-40f2-8480-33c6d79b3a2d
Category HUMAN OTC DRUG LABEL
Packager OMG Medical Group, LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Capsaicin 0.0375% USP

    Histamine Dihydrocholirde 0.035% USP

  • Warnings

    For external use only

    do not ingest

    use only as directed

    do not bandage tightly or use external heat or a heating pad

    avoid contact with eyes, mucus membranes, vagina, penis, scrotum and anus. If eye contact occurs, rinse thoroughly with water

    do not use on open wounds or damaged skin

    do not use if you are allergic to ingredients in this product

    stop and ask doctor if: condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, irritation develops, redness is present

    if swallowed, get medical help or contact a poison control center right away

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding as a health professional before use

  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cetyl Myristoleate, Cucumis Sativus
    (Cucumber) Extract, Ethylhexylglycerin,Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paragauyensis (Yerba Mate) Extract, Isopropyl Myristate, Methylsulfonylmethane (MSM), PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine

  • Directions

    Adults and children over 12 years: apply a thin leayer to the pain site and massage gently until thoroughly absorbed into the skin, repeat as necessary but not more than 4 times daily.

    Children 12 years or younger: ask a doctor

    Wash hands immediatly after use.

  • Other information

    store at controlled room temperature between 15 degrees C and 30 degrees C (59F-86F) with cap closed tight

    do not use if tamper resistant seal on jar is torn, broken or missing

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Pain relief

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PAINMD MAX 
    capsaicin, histamine dihydrocholoride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55992-404
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN3.75 mg  in 1 mg
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE3.5 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    water (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
    CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ILEX PARAGUARIENSIS WHOLE (UNII: QJB02841ZY)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55992-404-113.75 mg in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/22/2014
    Labeler - OMG Medical Group, LLC (038837214)
    Establishment
    NameAddressID/FEIBusiness Operations
    OMG Medical Group, LLC038837214repack(55992-404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source969241041manufacture(55992-404)

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