Label: REAL TIME PAIN RELIEF DAILY RELIEF (arnica montana- 2x h.p.u.s. lotion

  • 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 January 3, 2018

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  • Active Ingredient

    Arnica Montana (2X H.P.U.S.)

    *The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • Purpose

    Bruising, Stiffness, Pain

  • Uses:

    Temporarily relieves symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.

  • Warnings

    for external use only

  • When using this product

    avoid contact with eyes

  • Warnings and Precautions

    If swallowed, get medical help or contact a Poison Control Center immediately. Test for allergy by rubbing small amount on skin first. Do not use if allergic to or hypersensitive to any ingredient. If condition worsens or does not improve consult a doctor.

  • Stop use and ask a doctor

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • irritation develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep all medicines out of reach of children.

  • Directions

    Apply to affected area 2 times daily

    • or a needed.
  • Other Ingredients

    Purified Water, Methylsulfonylmethane, Sorbitol, Cetearyl Alcohol, SD Alcohol40, Cetyl Alcohol, Carbomer, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Emu Oil, Phenoxyethanol, Caprylyl Glycol, Triethanolamine, Gycerin, Myristica Fragrans (Nutmeg) Extract, Fragrance, Diazolidinyl Urea, Salix Alba (Willow) Bark Extract, Aloe Barbadensis Leaf Juice, Menthol, Extracts of: (Calendula officianlis (Marigold), Anthemis nobilis (Roman Chamomile), Tilia cordata (Lime Tree), Centaurea cyanus (Cornflower), Chamomilla recutita (Matricaria Chamomilla), Hypericum perforatum (St. John’s Wort)), Coriandrum Sativum (Coriander) Fruit Oil.

  • Package Label, Principal Display Panel and Drug Facts

    Label

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF DAILY RELIEF 
    arnica montana (2x h.p.u.s.) lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EMU OIL (UNII: 344821WD61)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SORBITOL (UNII: 506T60A25R)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOMER 934 (UNII: Z135WT9208)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALOE (UNII: V5VD430YW9)  
    MENTHOL (UNII: L7T10EIP3A)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    2,2-DICHLORO-1-(2-CHLOROPHENYL)ETHANOL (UNII: 1O5KW1KM6N)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    CLOPYRALID TRIETHANOLAMINE (UNII: O7T195VRMB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-300-1545 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2014
    2NDC:58133-300-04120 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2014
    3NDC:58133-300-12345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/2014
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Registrant - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-300)
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