Label: LABOFLEX ARNIPATCH MUSCLE AND JOINT PATCH- arnica montana patch

  • NDC Code(s): 83655-101-15, 83655-101-21
  • Packager: Laboflex, Inc.
  • 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 27, 2023

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  • Drug Facts

  • Active Ingredients

    Arnica Montana 1X - 7% HPUS

  • Purpose

    Muscle strain, Bruising

  • Uses

    • * For the temporary relief of muscle pain and stiffness due to minor injuries, overexertion and
      falls. Reduces pain, swelling and discoloration from bruises.
  • Warnings

    For external use only.

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

    When Using This Product

    When using this product■ Use only as directed ■ Do not bandage tightly ■ Avoid contact with eyes ■ Do not apply to open wounds or damaged skin

    Keep Out of Reach of Children

    Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

    Stop and ask doctor if

    Stop and ask doctor if■Condition worsens ■ Irritation occurs ■ Symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding

    If pregnant or breastfeeding, ask a health professional before use.

  • Directions

    Adults and children 12 years of age and over

    ■ Clean and dry affected area ■ Remove patch from film ■ Place healing patch on intact skin ■ Patch may be worn up to 12 hours.

    Children under 12 years of ageConsult a doctor

  • Inactive Ingredients

    Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Sodium, Glycerin, Methyl- paraben, Mint Oil, Partially Neutralized Polyacrylic Acid, Polysorbate 80, Povidone-K90, Propylparaben, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Purified Water

  • Questions of comments?

    Call toll-free 1-800-655-0252 or email: wooshinlabo-us@wooshinmed.com

  • Product Packaging

    Label

    Carton

  • INGREDIENTS AND APPEARANCE
    LABOFLEX ARNIPATCH MUSCLE AND JOINT PATCH 
    arnica montana patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83655-101
    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 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    WATER (UNII: 059QF0KO0R)  
    TARTARIC ACID (UNII: W4888I119H)  
    ALCOHOL (UNII: 3K9958V90M)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83655-101-155 g in 1 POUCH; Type 0: Not a Combination Product09/07/2023
    2NDC:83655-101-215 in 1 CARTON09/07/2023
    25 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/07/2023
    Labeler - Laboflex, Inc. (128394050)
    Registrant - Laboflex, Inc. (128394050)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOOSHIN LAPACHE d.o.o.507385209manufacture(83655-101)
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