Label: ARNICA PLUS- arnica montana, hypericum perforatum cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 14, 2018

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  • ACTIVE INGREDIENTS HPUS

    Arnica montana (Leopard`s bane) 1X

    Hypericum perforatum (St John`s wort) 1X

  • PURPOSE

    Pain, bruises, sprains.

    Bruises, strains.

  • REFERENCES

    The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

  • USES

    This homeopathic medicine helps relieve symptoms associated with:

    - minor bruises

    - strains

    - sprains.

  • WARNINGS


    For external use only.

    Do not use if tube seal is broken and on broken skin.

    When using this product, avoid contact with eyes.

    Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

    If pregnant or breast-feeding, 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

    Apply a thin layer to the affected area, rub in gently.

    Repeat 3 times a day or as needed.

  • OTHER INFORMATION

    Store at room temperature (68-77F).

  • INACTIVE INGREDIENTS

    Carbomer, ceteareth-12, cetearyl alcohol, cetyl alcohol, cetyl palmitate, DMDM hydantoin, glycerin, glyceryl cocoate, glyceryl stearate, iodopropynyl butylcarbamate, isopropyl myristate, isopropyl palmitate, octyldodecanol, PEG-20 glyceryl stearate, PEG-100 stearate, purified water, sodium hydroxide, sorbitan stearate.

  • CARTON

    image of carton label

  • TUBE

    image of tube label

  • INGREDIENTS AND APPEARANCE
    ARNICA PLUS 
    arnica montana, hypericum perforatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 50 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM1 [hp_X]  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9082-11 in 1 CARTON06/01/2011
    150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2011
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9082)
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