Label: ARNICA ACTIVE ROLL-ON- arnica montana liquid

  • 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 December 12, 2016

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  • SPL UNCLASSIFIED SECTION

    Arnica Active® Roll-On

    Drug Facts

  • Active Ingredients

    Arnica montana 1X

  • Purpose

    bruises, swelling, aches, sprains, muscle pain, soreness, and stiffness

  • Uses*

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
    • bruising & swelling
    • sprains
    • backaches
    • muscular aches & pains
    • strains
    • stiffness

  • Warnings

    • FOR EXTERNAL USE ONLY. Do not use on damaged skin, open wounds, or mucous membranes.

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

    • Avoid contact with the eyes.

    • Do not use if you are allergic to Arnica montana (Asteracea flower) or any of this product’s inactive ingredients.

    • Do not bandage tightly or use with a heating pad.

    • If conditions worsen or if symptoms persist for more than 72 hours or clear up and occur again within a few days, discontinue use of this product and consult a physician.

    If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For adults and children age 2 and over:

    Apply a thin layer to affected area soon as possible after minor injury. Repeat 3 times a day or as needed.

  • Other Information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients

    USP water, carbomer, sodium hydroxide, USP ethanol, PEG-8 dimethicone

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

    www.SimilasanUSA.com

    *These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-102-42
    Similasan
    Arnica
    Active
    Roll-On
    Pain Relief
    74 ml/ 2.5 fl oz

    PRINCIPAL DISPLAY PANEL NDC 59262-102-42 Similasan Arnica Active Roll-On Pain Relief 74 ml/ 2.5 fl oz

  • INGREDIENTS AND APPEARANCE
    ARNICA ACTIVE ROLL-ON 
    arnica montana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-102-4274 mL in 1 APPLICATOR; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2017
    Labeler - Similasan Corporation (111566530)
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