PAIN RELIEVING ARTHRITIS (HISTAMINE DIHYDROCHLORIDE) CREAM [VELOCITY PHARMA LLC]

PAIN RELIEVING ARTHRITIS (HISTAMINE DIHYDROCHLORIDE) CREAM [VELOCITY PHARMA LLC]
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NDC 76168-300-38
Set ID 20137af7-3494-45c6-97e1-f6ecef6354af
Category HUMAN OTC DRUG LABEL
Packager Velocity Pharma LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Histamine dihydrochloride ...... 0.025%

  • Purpose

    External Analgesic

  • Uses

    • For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains & bruises.
  • Warnings

    • For external use only.
    • Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.
  • When using this product

    • avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
    • do not bandage tightly or use a heating pad.
  • Stop use and ask a doctor if

    • rash appears.
    • condition worsens, if symptoms persist for more than 7 days, or if 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • For Use by Adults and Children over 12 years.
    • Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.
    • Children 12 years or younger consult a physician.
  • Other information

    • Store between 40°F and 86°F ( 4°C and 30C).
    • Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.
  • Inactive ingredients

    arylamide, butylated hydroxyl toluene, cetostearyl alcohol , cetomacrogol 1000, disodium EDTA, glucosamine sulfate, glycerin, isohexadecane, polysorbate 80,  propylene glycol, sodium acrylodimethyl taurate copolymer, titanium dioxide, transquitol P, vitamin E acetate,  white petroleum jelly, water

  • Questions or Comments? Call 1855-314-1850

    Distributed by: Velocity Pharma LLC 
    Farmingdale, NY, 11735

  • PRINCIPAL DISPLAY PANEL

    Pain Relieving Arthritis Cream

    Net Wt. 4 oz (119g)

    ra Arthritis

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING ARTHRITIS 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLAMIDE (UNII: 20R035KLCI)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-300-38119 g in 1 JAR; Type 0: Not a Combination Product05/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/26/2017
    Labeler - Velocity Pharma LLC (962198409)
    Registrant - Velocity Pharma LLC (962198409)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yash Pharmceuticals871409551manufacture(76168-300)
    Establishment
    NameAddressID/FEIBusiness Operations
    Velocity Pharma LLC962198409label(76168-300)

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