Label: KIDS RELIEF ARNICA- 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 February 20, 2014

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  • ACTIVE INGREDIENTS HPUS

    Arnica montana (Leopard's bane) 1X
    Hypericum perforatum (St John's Wort) 1X

  • PURPOSE

    Pain, bruises, sprains, muscle aches

    Bruises, strains

    These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

  • REFERENCES

    The letters "HPUS" indicate that the ingredients in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

  • USES

    This homeopathic medecine is made from a combination of ingredients traditionally used to help relieve symptoms associated with:

    - minor bruises

    - strains

    - sprains

    - muscle aches

  • WARNINGS


    For external use only.

    Do not use on broken skin.

    When using this product, avoid contact with eyes; if contact occurs, rinse abundantly with water to remove.

    Stop use and ask a doctor

    - if symptoms persist for more than 3 days or worsen

    - if hypersensitivity and/or allergy occurs.

    Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    - Apply a thin layer to the affected area, rub in gently. Repeat 3 times a day or as needed.

    - Children under 2 yrs: ask a doctor.

  • OTHER INFORMATION

    - Store at room temperature (68 - 77°F)

    - Do not use if tube seal is broken.

  • 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
    KIDS RELIEF ARNICA 
    arnica montana, hypericum perforatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9086
    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
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9086-11 in 1 CARTON
    150 g in 1 TUBE
    2NDC:60512-9086-26 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/15/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9086)
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