Label: ROPANA PAIN RELIEF CREAM- histamine dihydrochloride cream

  • NDC Code(s): 83613-411-00
  • Packager: FUSION PAIN SOLUTIONS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredients

    Histamine DHCl 0.04%

    Purpose

    Topical Analgesic

  • Uses:

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

  • Warnings:

    For external use only

    Do not use

    • on damaged or broken skin.

    When using this product

    • Avoid contact with the eyes.

    Stop use and ask a doctor if

    • Rash or irritation develops and lasts.
    • Condition worsens, or if symptoms 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. 

    If pregnant or breast-feeding,

    ask a health professional before use

  • Directions:

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Chldren under 2 years of age: consult a doctor.
  • Other Information:

    Protct the product in this container from excessive heat and direct sun.

  • Inactive ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cinnamomum Cassia Oil, Curcuma Longa (Turmeric) Extract, Cyclopentasiloxane, Dodecane, Ethylhexylglycerin, Ethyl Vanillin, Glyceryl Stearate, Glycyrrhiza Glaba (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Stearic Acid, Triethanolamine, Xanthan Gum.

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    ROPANA PAIN RELIEF CREAM 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83613-411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DODECANE (UNII: 11A386X1QH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    TURMERIC (UNII: 856YO1Z64F)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83613-411-00118 mL in 1 JAR; Type 0: Not a Combination Product08/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/21/2023
    Labeler - FUSION PAIN SOLUTIONS LLC (124386338)
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