Label: BRUISES GONE GEL- calendula officinalis, arnica montana, hypericum perforatum, symphytum officinale, bellis perennis, ledum palustre, sulphuricum acidum 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 August 8, 2013

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  • ACTIVE INGREDIENTS:

    Calendula Officinalis 1X, Arnica Montana 1X, 30C, Hypericum Perforatum 1X, 30C, Symphytum Officinale 3X, Bellis perennis 12X, Ledum Palustre 12X, Sulphuricum Acidum 12X, Calcarea Fluorica 30X, Ferrum Phosphoricum 30X, Rhus Toxicodendron 30X, Ruta Graveolens 30X, Natrum Sulphuricum 30C.

  • INDICATIONS:

    For temporary relief of bumps, bruises, abrasions, strains, sprains, fractures, stiffness, for all body injuries.

  • WARNINGS:

    ​If 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.

    Do not use if tamper evident seal is broken or missing.

    ​For topical use only.​

  • STORAGE:

    Store in a cool, dry place.

  • DIRECTIONS:

    Apply a small amount every 10 minures for 3 doses immediately after injury, then 2 to 3 times daily.

  • INACTIVE INGREDIENTS:

    Biosaccharide Gum-1, Carbomer, Ethanol, Glycerin, NaPCA, Purified Water, Sodium Hydroxymethylglycinate, Tromethamine.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • INDICATIONS:

    For temporary relief of bumps, bruises, abrasions, strains, sprains, fractures, stiffness, for all body injuries.

  • QUESTIONS:

    Dist. By: MedCare Group

    Boothwyn, PA 19060

    302-260-3111

    www.medcaregroups.com

  • PACKAGE DISPLAY LABEL:

    MedCare

    Bruises Gone Gel

    HOMEOPATHIC

    Net Wt. 2 oz

    image description

  • INGREDIENTS AND APPEARANCE
    BRUISES GONE GEL 
    calendula officinalis, arnica montana, hypericum perforatum, symphytum officinale, bellis perennis, ledum palustre, sulphuricum acidum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54557-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM1 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS12 [hp_X]  in 1 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG12 [hp_X]  in 1 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID12 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [hp_X]  in 1 mL
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM30 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP30 [hp_X]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54557-0002-160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/08/2013
    Labeler - MedCare Group LLC (038668689)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(54557-0002) , api manufacture(54557-0002) , label(54557-0002) , pack(54557-0002)
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