Label: ARTHRITIS PAIN RELIEF- histamine dihydrochloride 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 November 7, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    HISTAMINE DIHYDROCHLORIDE 0.03%

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and 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 using and ask doctor if

    • Rash appears.
    • Condition worsens, if symptoms persists for more than 7 days, or if symptoms clear up and occur again within a few days.
  • 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.
  • PREGNANCY

    IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTRE RIGHT AWAY.

  • OTHER INFORMATION

    • Store between 40°F and 86°F (4°C and 30°C)
    • Tamper Evident Feature: do not use if seal under cap is torn, broken or missing.
  • INACTIVE INGREDIENTS

    Water, Cetearyl Alcohol, Dimethicone, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Methylsulfonylmethane, Glyceryl Stearate, PEG-100 Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Emu Oil, Stearic
    Acid, Tocopheryl (Vitamin E) Acetate, Glucosamine Hydrochloride, Phenoxyethanol, Menthol, Carbomer, Curcuma Longa (Turmeric) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Triethanolamine, Ethyhexylglycerin, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    01b UC_PainX_119

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEF 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83041-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.03 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TURMERIC (UNII: 856YO1Z64F)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    EMU OIL (UNII: 344821WD61)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83041-101-14119 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/07/2022
    Labeler - PainX LLC (118688116)
    Registrant - PainX LLC (118688116)