Label: ARNICA GEL- arnica montana gel

  • NDC Code(s): 81417-005-01
  • Packager: Sled Distribution, LLC
  • 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, 2024

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  • Active ingredients:

    Arnica montana 7%

  • Purpose

    Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

  • INDICATIONS & USAGE

    Uses Temporarily relieves muscle pain and stiffness due to:

    • minor injuries
    • overexertion
    • falls 
    • reduces symptoms of bruising such as : discoloration, pain, swelling.
  • WARNINGS

    WarningsFor external use only.

  • DO NOT USE

    Do not use if you are allergic to Arnica montana or any of this product's inactive ingredients.

  • WHEN USING

    When using this product

    • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
    • dryness or irritation may occur
    • use only as directed
    • do not tightly wrap or bandage the treated area
    • do not apply heat or ice to the treated area immediately before or after use.
  • STOP USE

    Stop use and ask a doctor if

    • Conditions persist for more than 3 days or worsens
    • Symptoms clear up and occur again within a few days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center immediately.
  • DOSAGE & ADMINISTRATION

    Directions

    Apply a thin layer of gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying ointment.

  • OTHER SAFETY INFORMATION

    Other information do not use if the sachet seal is broken.

  • INACTIVE INGREDIENT

    Alcohol, carbomer, purified water, propylene glycol, sodium hydroxide

  • PRINCIPAL DISPLAY PANEL

    image of pouch label

  • INGREDIENTS AND APPEARANCE
    ARNICA GEL 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81417-005-013.5 g in 1 POUCH; Type 0: Not a Combination Product08/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/29/2022
    Labeler - Sled Distribution, LLC (079772888)
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