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

PAIN RELIEVING ARTHRITIS (HISTAMINE DIHYDROCHLORIDE) CREAM [VELOCITY PHARMA LLC]
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NDC 76168-108-45
Set ID 80f404f6-5ee5-401d-8c02-c6f49f344f3c
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

    butylated hydroxyl toluene, cetostearyl alcohol , cetomacrogol 1000, cetyl alcohol, disodium EDTA, disodium hydrogen phosphate, light liquid paraffin, propylene glycol, sorbic acid, transquitol P, white petroleum jelly

  • 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) Arthritis Pain Relief Cream

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING ARTHRITIS 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-108
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-108-45119 g in 1 JAR; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2017
    Labeler - Velocity Pharma LLC (962198409)
    Registrant - Velocity Pharma LLC (962198409)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yash Pharmceuticals871409551manufacture(76168-108)
    Establishment
    NameAddressID/FEIBusiness Operations
    Velocity Pharma LLC962198409label(76168-108)

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