REAL TIME PAIN RELIEF HEMP OIL PLUS (ARNICA MONTANA) CREAM [COSMETIC SPECIALTY LABS, INC.]

REAL TIME PAIN RELIEF HEMP OIL PLUS (ARNICA MONTANA) CREAM [COSMETIC SPECIALTY LABS, INC.]
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NDC 58133-101-04, 58133-101-12, 58133-101-15
Set ID 62d7422a-1d5a-164f-e053-2a91aa0acec7
Category HUMAN OTC DRUG LABEL
Packager Cosmetic Specialty Labs, Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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, Tocopheryl Acetate, Emu Oil, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Caprylyl Glycol, Carbomer, Triethanolamine, Fragrance, Glycerin, Curcuma Longa (Tumeric) Root Extract, Wasabi Japonica Root Extract, Salix Alba (Willow) Bark Extract, Mentha Piperita (Peppermint) Leaf Oil, Industrial Hemp Seed Oil, Menthol, Extracts of: (Calendula officinalis (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.

  • Principal Display Panel and Drug Facts

    Labeling

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF HEMP OIL PLUS 
    arnica montana cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-101
    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 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHANOLAMINE LAURYLAMINOPROPIONATE (UNII: 793J74ICPW)  
    CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
    WASABI ROOT (UNII: 69JM5DKE22)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SORBITOL (UNII: 506T60A25R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EMU OIL (UNII: 344821WD61)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    MENTHOL (UNII: L7T10EIP3A)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK)  
    HEMP (UNII: TD1MUT01Q7)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    HYPERICUM PERFORATUM LEAF (UNII: DOC7OB843Y)  
    CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-101-04114 g in 1 TUBE; Type 0: Not a Combination Product01/01/2015
    2NDC:58133-101-12340 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2015
    3NDC:58133-101-1542 g in 1 TUBE; 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(58133-101)

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