Label: HOMEOPATHIC LIP BALM- arnica montana ointment

  • 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 8, 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

    Pain

  • Uses

    Temporarily relieves symptoms of pain and inflammation.

  • Warnings

    For external use only.

    • 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.
  • When using this product

    • Avoid contact with eyes
  • 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.

  • Inactive Ingredients

    Petrolatum, Synthetic Beeswax, Isopropyl Palmitate, Menthol, Lanolin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Natural Flavor, Lavandula Angustifolia (Lavender) Oil, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Butyrospermum Parkii (Shea) Butter, Mentha Piperita (Peppermint) Leaf Oil, Isopropyl Myristate, Also Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) See Oil, Camphor, Butylene Glycol, Stevia Rebaudiana Leaf/Stem Extract.

  • Principal Display Panel, Drug Facts

    labeling

  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC LIP BALM 
    arnica montana ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA2 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR LEAF OIL (UNII: 51D0RGY52V)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
    BUTYROSPERMOL (UNII: 6SF0L0FL42)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-111-0515 g in 1 JAR; Type 0: Not a Combination Product01/01/2015
    2NDC:58133-111-015.5 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(58133-111)
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