Label: ARNICA PERFORMANCE GEL- arnica montana gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 25, 2015

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient: Arnica Montana 15%

  • PURPOSE

    Purpose:Trauma, bruises, stiffness, muscle soreness

     

  • INDICATIONS & USAGE

    For relief of muscle aches and stiffness due to minor injuries such as strains, falls and blows. Reduces pain, swelling, and discoloration from bruises.

  • WARNINGS

    Warnings: For external use only.
    Avoid contact with eyes and with open wounds. Do not use on broken skin

    Stop use and ask a doctor if condition persists for more than 3 days or worsens.

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

    Directions: Apply Arnica Performance Gel to affected area as soon as possible after minor injury.

    Repeat 3 times a day or as needed

    Other Information: Store at 68-77 F (20-25 C)

    Inactive Ingredients

    Aloe Barbadensis, Caprylic /Capric Triglyceride, Caprylyi Glycol, Carbomer, Deionized Water, Glycerin, Ilex Paraguariensis Extract, Isoprpyl Alcohol, IsodecylNeopentanoate, Lecithin, MSM, Phenoxyethanol, Sorbic Acid, Triethanolamine & Vitamin E

    Question or Comments? 1-800-803-1535

  • PRINCIPAL DISPLAY PANEL

    arnica_2oz_gel.jpg                       arnica_3oz_ roll_on.jpg

  • INGREDIENTS AND APPEARANCE
    ARNICA PERFORMANCE GEL 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41391-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41391-121-2159 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41391-121-2089 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/25/2015
    Labeler - Myo-Breathe,LLC (003635412)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!