Label: GLUCOSAMINE CREAM EXTRA STRENGTH- 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 January 17, 2022

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

  • Drug Facts

  • Active Ingredient

    Histamine Dihydrochloride 0.05%

  • Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

  • WARNINGS

    Warnings For external use only

    When using this product

    • Avoid contact with eyes
    • Do not bandage tightly

    Do not use 

    • On wounds or damaged skin or if you are allergic to ingredients in this product.

    Discontinue use and consult a physician if: Condition worsens or if symptoms persists for more than 7 days or clear up and occur again within a few days

  • Keep out of reach of children.

    If swallowed get medical help or contact a poison control center

  • Directions

    For use by adults and children over 12 years:

    Apply to affected area not more than 3 to 4 times daily.

  • INACTIVE INGREDIENT

    Inactive ingredients Deionized water, cetearyl alcohol, emu oil, glycerine, ceteareth-20, glucosamine sulfate, dimethyl sulfone, caprylic capric triglyceride, phenoxyethanol, cetyl alcohol, methyl paraben, tocopherol acetate, butylene glycol, propylene glycol, chamomilla recutita flower extract, rosmarinus officinalis leaf extract, boswellia serrata extract, propyl paraben

  • SPL UNCLASSIFIED SECTION

    Pain Relief On Contact

    Dual Action Moisturizing Cream

    Odorless, Greaseless, Stainless.

    Made in USA

    For re-orders call 800-280-5590

    www.drnewtons.com

    Distributed by

    Dr. Newton's Naturals

    26 Thomas Drive

    Westbrook, ME 04092

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    GLUCOSAMINE CREAM EXTRA STRENGTH 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52099-0008
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ROSEMARY (UNII: IJ67X351P9)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52099-0008-385 g in 1 TUBE; Type 0: Not a Combination Product04/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2017
    Labeler - Q.A. Laboratories (065361149)
    Establishment
    NameAddressID/FEIBusiness Operations
    Q.A. Laboratories065361149manufacture(52099-0008)