Label: HEMORRHOIDS- elaps corallinus, aesculus hipp., aloe, arsenicum alb., bryonia, calc. fluor., capsicum, collinsonia, crotalus horridus, hamamelis, hydrofluoricum acidum, hypericum, lachesis, lycopodium, millefolium, naja, nux vom., paeonia, plantago, quercus glandium spiritus, ratanhia, vipera berus, echinacea, solidago, urtica ur. liquid

  • 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 1, 2011

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE SECTION

    Hemorrhoids  Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Elaps corallinus 30x, Aesculus hipp.15x, Aloe 15x, Arsenicum alb. 15x, Bryonia 15x, Calc. fluor. 15x, Capsicum 15x, Collinsonia 15x, Crotalus horridus 15x, Hamamelis 15x, Hydrofluoricum acidum 15x, Hypericum 15x, Lachesis 15x, Lycopodium 15x, Millefolium 15x, Naja 15x, Nux vom. 15x, Paeonia 15x, Plantago 15x, Quercus glandium spiritus 15x, Ratanhia 15x, Vipera berus 15x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%

  • QUESTIONS SECTION

    www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions?  1.800.448.7256 

  • WARNINGS SECTION

    Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children

  • PACKAGE LABEL.

    package label

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDS  
    elaps corallinus, aesculus hipp., aloe, arsenicum alb., bryonia, calc. fluor., capsicum, collinsonia, crotalus horridus, hamamelis, hydrofluoricum acidum, hypericum, lachesis, lycopodium, millefolium, naja, nux vom., paeonia, plantago, quercus glandium spiritus, ratanhia, vipera berus, echinacea, solidago, urtica ur. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2220
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom30 [hp_X]  in 1 mL
    Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ) Horse Chestnut15 [hp_X]  in 1 mL
    Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9) Aloe15 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O) Calcium Fluoride15 [hp_X]  in 1 mL
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum15 [hp_X]  in 1 mL
    Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR) Collinsonia Canadensis Root15 [hp_X]  in 1 mL
    Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom15 [hp_X]  in 1 mL
    Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS) (Hamamelis Virginiana Root Bark/stem Bark - UNII:T7S323PKJS) Hamamelis Virginiana Root Bark/stem Bark15 [hp_X]  in 1 mL
    Hydrofluoric Acid (UNII: RGL5YE86CZ) (Hydrofluoric Acid - UNII:RGL5YE86CZ) Hydrofluoric Acid15 [hp_X]  in 1 mL
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum15 [hp_X]  in 1 mL
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
    Achillea Millefolium (UNII: 2FXJ6SW4PK) (Achillea Millefolium - UNII:2FXJ6SW4PK) Achillea Millefolium15 [hp_X]  in 1 mL
    Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
    Paeonia Officinalis Root (UNII: 8R564U2E1P) (Paeonia Officinalis Root - UNII:8R564U2E1P) Paeonia Officinalis Root15 [hp_X]  in 1 mL
    Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major15 [hp_X]  in 1 mL
    Quercus Robur Nut (UNII: Q7MU1F4GLY) (Quercus Robur Nut - UNII:Q7MU1F4GLY) Quercus Robur Nut15 [hp_X]  in 1 mL
    Krameria Lappacea Root (UNII: P29ZH1A35Z) (Krameria Lappacea Root - UNII:P29ZH1A35Z) Krameria Lappacea Root15 [hp_X]  in 1 mL
    Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom15 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 mL
    Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2220-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-2220-259.14 mL in 1 BOTTLE, GLASS
    3NDC:55714-2220-0.5 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-2220) , API MANUFACTURE(55714-2220)