Label: HEMORRHOID CARE- hamamelis virginiana, aesculus hippocastanum, aloe socotrina, paeonia officinalis, ignatia amara, lycopodium clavatum, nitricum acidum, nux vomica, phosphorus, podophyllum peltatum, pulsatilla, sulphur, ratanhia, chelidonium majus, 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 January 26, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Hamamelis virginiana 1X, Aesculus hippocastanum 1X, 30C, Aloe socotrina 6X, Paeonia officinalis 6X, Ignatia amara 12X, Lycopodium clavatum 12X, Nitricum acidum 12X, Nux vomica 12X, Phosphorus 12X, Podophyllum peltatum 12X, Pulsatilla 12X, Sulphur 12X, Ratanhia 12X, 30X,  Chelidonium majus 30C.

  • PURPOSE

    INDICATIONS:  For temporary relief of itching and discomfort associated with hemorrhoids.

  • WARNINGS

    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.

    Store in a cool, dry place

    For topical use only.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  Apply a small amount externally to the affected area up to 6 times daily or after each bowel movement.  Children under 12 years of age: Consult a doctor.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Citric acid, Ethanol, Glycerin, Hydroxyethylcellulose, Purified water, Sodium benzoate.

  • 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 & USAGE

    INDICATIONS:  For temporary relief of itching and discomfort associated with hemorrhoids.

  • QUESTIONS

    Dist. By:

    MedCare Group

    Boothwyn, PA 19060

    302-260-3111

    www.medcaregroups.com


  • PRINCIPAL DISPLAY PANEL

    MEDCARE

    Hemorrhoid Care

    HOMEOPATHIC GEL

    Net. Wt. 2 OZ

    Hemorrhoid Care

  • INGREDIENTS AND APPEARANCE
    HEMORRHOID CARE 
    hamamelis virginiana, aesculus hippocastanum, aloe socotrina, paeonia officinalis, ignatia amara, lycopodium clavatum, nitricum acidum, nux vomica, phosphorus, podophyllum peltatum, pulsatilla, sulphur, ratanhia, chelidonium majus, gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0778
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 1 g
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT1 [hp_X]  in 1 g
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE6 [hp_X]  in 1 g
    PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT6 [hp_X]  in 1 g
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_X]  in 1 g
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 g
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID12 [hp_X]  in 1 g
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 g
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 g
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM12 [hp_X]  in 1 g
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 1 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 g
    KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT12 [hp_X]  in 1 g
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS30 [hp_C]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0778-156.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/08/2011
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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