Label: ARNICA GEL- arnica montana gel

  • 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 March 24, 2022

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  • ACTIVE INGREDIENT

    Drug Facts__________________________________________________________________________________________________________

    Active ingredient:

    Arnica montana -7%

    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

    Warnings:

    • For external use only. Avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin.
    • If pregnant or breast-feeding, ask a health professional before use.
    • Nursing mothers should not apply to breast area.
    • Keep out of reach of children.
    • Stop use and ask a doctor if: •symptoms worsen or do not improve within 3 days •skin irritation, redness or rash occurs.
  • 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 get to affected area as soon as possible after minor injure. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying ointment.

  • OTHER SAFETY INFORMATION

    Other information:

    • Do not use if carton or tube seal is broken.
  • INACTIVE INGREDIENT

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

  • PURPOSE

    Drug Facts

    ____________________________________________________________________________________________________________________

    Active ingredients                                   Purpose

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ARNICA GEL 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-123
    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:81417-123-011 in 1 PACKET03/24/2022
    13.5 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/24/2022
    Labeler - Sled Distribution, LLC (079772888)
    Registrant - Sled Distribution, LLC (079772888)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sled Distribution, LLC079772888manufacture(81417-123)
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