Label: REAL TIME PAIN RELIEF SELECT PLUS HEMP OIL- arnica montana 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 15, 2018

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Arnica Montana (3X H.P.U.S.)

  • Purpose

    Bruising, Stiffness, Pain

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

  • 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
    • 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 if:

    • 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 as needed.

  • Other Ingredients:

    Aloe Barbadensis Leaf Juice, Purified Water, Methylsulfonylmethane, Sorbitol, Cetearyl Alcohol, Cetyl Alcohol, SD Alcohol 40, Butylene Glycol, Hamamelic Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Caprylyl Glycol, Fragrance, Carbomer, Triethanolamine, Salix Alba (Willow) Bark Extract, Industrial Hemp Seed Oil, Menthol, Capsicum Frutescens Fruit, Calendula officinalis (Marigold), Anthemis nobilis (Roman Chamomile), Tilia cordata (Lime Tree), Centaurea cyanus (Cornflower), Chamomilla recueta (Matricaria Chamomilla), Hypericum perforatum (St. John’s Wort), Coriandrum Saevum (Coriander) Fruit Oil.

  • SPL UNCLASSIFIED SECTION

    There is no scientific evidence that homeopathic products work. The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

    100% VEGAN

  • Principal Display Panel and Drug Facts

    Labeling

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF SELECT PLUS HEMP OIL 
    arnica montana lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    HEMP (UNII: TD1MUT01Q7)  
    CAPSICUM FRUTESCENS WHOLE (UNII: 6XJX33L87P)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MENTHOL (UNII: L7T10EIP3A)  
    CHAMOMILE (UNII: FGL3685T2X)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-800-0388 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2015
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Registrant - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-800)