Label: PAIN RELIEVING CREAM- histamine dihydrochloride cream

  • NDC Code(s): 85063-101-85
  • Packager: Mediapower, Inc. DBA Dr Newton's And Naturals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 19, 2025

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

  • Drug Facts

  • Active ingredient

    Histamine dihydrochloride 0.05% w/w

  • Purpose

    Pain reliever

  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

  • Warnings

    For external use only

    Do not use • on wounds or damaged skin • if you are allergic to ingredients in this product

    When using this product • avoid contact with the eyes. If product gets into the 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, or if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days

    If pregnant or breastfeeding, 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

    • adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily • children under 12 years of age: do not use, consult a physician

  • Other information

    store between 68° and 77° F (20° and 25° C)

  • Inactive ingredients:

    Water, Cetearyl alcohol, Emu oil, Glycerin, Ceteareth-20, Glucosamine sulfate, Dimethyl sulfone, Caprylic/capric triglyceride, Phenoxyethanol, Cetyl alcohol, Tocopherol acetate, Butylene glycol, Propylene glycol, Chamomile (Chamomilla recutita) flower extract, Rosemary (Rosemarinusofficinalis) leaf extract, Indian frankincense (Boswellia serrata) extract, Ethylhexylglycerin.

  • Questions or comments?

    +1-866-788-5951

    You may also report serious side effects to this phone number.

    Mon-Fri 8:00 A.M. - 6:00 P.M.

  • SPL UNCLASSIFIED SECTION

    DR. NEWTON'S™ NATURALS

    Temporary Pain Relief

    Moisturizing Cream

    Odorless, Greaseless, Stainless

    Distributed by
    Dr. Newton's Naturals
    26 Thomas Drive,
    Westbrook, ME 04092

    To re-order call 800-280-5590

    MADE IN USA

    www.drnewtons.com

  • Packaging

    PainRelieving1

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING CREAM 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85063-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EMU OIL (UNII: 344821WD61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ROSEMARY (UNII: IJ67X351P9)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85063-101-8585 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/20/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/20/2025
    Labeler - Mediapower, Inc. DBA Dr Newton's And Naturals (883666190)