Label: HEMORRHOID GEL- achillea millefolium, aesculus hippocastanum, hamamelis virginiana, ruscus aculeatus, aloe socotrina, paeonia officinalis, ignatia amara, nitricum acidum, nux vomica, phosphorus, podophyllum peitatum, pulsatilla, ratanhia, chelidonium majus, sulphur gel

  • NDC Code(s): 43406-0709-5
  • Packager: Natural Creations, 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 21, 2018

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS - equal amounts of: Achillea Millefolium 4X, Aesculus Hippocastanum 4X, 30C, Hamamelis Virginiana 4X, Ruscus Aculeatus 4X, Aloe Socotrina 6X, Paeonia Officinalis 6X, Ignatia Amara 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphorus 12X, Podophyllum Peitatum 12X, Pulsatilla 12X, Ratanhia 12X, 30C, Chelidonium Majus 30C, Sulphur 30C

  • INDICATIONS & USAGE

    USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

  • PURPOSE

    USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Lubricate applicator with a small amount of gel before use. Apply to area 5 to 6 times daily, especially after a bowel movement.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

  • WARNINGS

    WARNINGS:

    • FOR TOPICAL USE ONLY.
    • Consult a physician for use in children under 12 years of age.
    • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
    • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
    • Do not use if TAMPER EVIDENT seal is broken or missing.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Carbomer 980, Ethanol Alcohol, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxide, USP Glycerin

  • QUESTIONS

    QUESTIONS & COMMENTS?

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • PRINCIPAL DISPLAY PANEL

    NDC:43406-0709-5

    Hemorrhoid Gel

    HOMEOPATHIC

     2 oz (56.7g)

    image description

  • INGREDIENTS AND APPEARANCE
    HEMORRHOID GEL 
    achillea millefolium, aesculus hippocastanum, hamamelis virginiana, ruscus aculeatus, aloe socotrina, paeonia officinalis, ignatia amara, nitricum acidum, nux vomica, phosphorus, podophyllum peitatum, pulsatilla, ratanhia, chelidonium majus, sulphur gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0709
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM WHOLE4 [hp_X]  in 1 g
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK4 [hp_X]  in 1 g
    RUSCUS ACULEATUS WHOLE (UNII: 5KEZ82GMGU) (RUSCUS ACULEATUS WHOLE - UNII:5KEZ82GMGU) RUSCUS ACULEATUS WHOLE4 [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
    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 WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE12 [hp_X]  in 1 g
    KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT30 [hp_C]  in 1 g
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT30 [hp_C]  in 1 g
    CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE30 [hp_C]  in 1 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0709-556.7 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product09/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/12/2019
    Labeler - Natural Creations, Inc (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc030572478manufacture(43406-0709)
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