Label: ARTHRITIS PAIN RELIEF CREAM- histamine dihydrochloride cream

  • NDC Code(s): 61577-8120-1, 61577-8120-2, 61577-8120-4, 61577-8120-5, view more
    61577-8120-8, 61577-8120-9
  • Packager: Sombra Cosmetics Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 21, 2026

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

  • Active Ingredients

    Histamine Dihydrochloride .025%

  • Purpose

    External Analgesic

  • Keep out of reach of children

    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center right away

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backaches, 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 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.

  • 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.

  • Inactive Ingredients

    Aqua (Purified Water), Butylene Glycol, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Helianthus
    Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Methylsulfonylmethane (MSM),
    Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate
    (Vitamin E), Trideceth-6, Chondroitin Sulfate, Glucosamine Sulfate

  • Questions or Comments

    Call 1-888-600-4642

  • Dosage and Administration

    Apply no more than 3 to 4 times daily.

  • Warnings Section

    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 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.

  • Indications and Usage Section

    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.

  • AD Arthritis 9oz Carton

    AD Arthritis 9oz Carton

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEF CREAM 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-8120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.00025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HELIANTHUS ANNUUS (SUNFLOWER) SEED (UNII: R9N3379M4Z)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    TETRASODIUM EDTA (UNII: MP1J8420LU)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    EMU OIL (UNII: 344821WD61)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    WATER (UNII: 059QF0KO0R)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-8120-51 in 1 CARTON10/23/2024
    1NDC:61577-8120-4119 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:61577-8120-81 in 1 CARTON10/23/2024
    2NDC:61577-8120-9266 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:61577-8120-11 in 1 CARTON10/23/2024
    3NDC:61577-8120-259 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/23/2024
    Labeler - Sombra Cosmetics Inc. (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sombra Cosmetics Inc.097464309manufacture(61577-8120) , label(61577-8120)