MUSCLESHOK BACK PAIN (HISTAMINE DIHYDROCHLORIDE) GEL [WAGNER SOLUTIONS, LLC]

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MUSCLESHOK BACK PAIN (HISTAMINE DIHYDROCHLORIDE) GEL [WAGNER SOLUTIONS, LLC]
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NDC 72378-013-01
Set ID f364f6b5-8260-40ad-adf6-a8d44fbf58b1
Category HUMAN OTC DRUG LABEL
Packager Wagner Solutions, LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active ingredient

    Histamine dihydrochloride 0.05%

    Purpose

    Topical Analgesic

  • Uses

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

  • Warnings

    For external use only

    when using this product

    • do not bandage tightly
    • do not apply to wounds or damaged skin
    • avoid contact with eyes or mucous membranes

    Stop use and ask a doctor if

    • condition worsens
    • sympotms persist 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 right away.

  • Directions

    • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
    • Children under 2 years of age: do not use; consult a doctor
  • Other information

    store at room temperature

  • Inactive Ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Methylsulfonylmethane (MSM), Phenoxyethanol, Triethanolamine, Water (Aqua)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MUSCLESHOK BACK PAIN 
    histamine dihydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72378-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72378-013-01118 mL in 1 TUBE; Type 0: Not a Combination Product02/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/20/2019
    Labeler - Wagner Solutions, LLC (098004226)
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