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
- NDC Code(s): 55714-4845-1
- Packager: Newton Laboratories, 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 July 12, 2021
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Aesculus hippocastanum 11x, Echinacea 11x, Solidago virgaurea 11x, Urtica urens 11x, Aesculus hippocastanum 20x, Aloe 20x, Arsenicum album 20x, Bryonia 20x, Calcarea fluorica 20x, Capsicum annuum 20x, Collinsonia canadensis 20x, Crotalus horridus 20x, Hamamelis virginiana 20x, Hydrofluoricum acidum 20x, Hypericum perforatum 20x, Lachesis mutus 20x, Lycopodium clavatum 20x, Millefolium 20x, Naja tripudians 20x, Nux vomica 20x, Paeonia officinalis 20x, Plantago major 20x, Quercus glandium spiritus 20x, Ratanhia 20x, Vipera berus 20x, Elaps corallinus 35x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL.
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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. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4845 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICRURUS CORALLINUS VENOM (UNII: V0S6H36980) (MICRURUS CORALLINUS VENOM - UNII:V0S6H36980) MICRURUS CORALLINUS VENOM 35 [hp_X] in 1 mL HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 20 [hp_X] in 1 mL ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE 20 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 20 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 20 [hp_X] in 1 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 20 [hp_X] in 1 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 20 [hp_X] in 1 mL COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT 20 [hp_X] in 1 mL CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM 20 [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 BARK 20 [hp_X] in 1 mL HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 20 [hp_X] in 1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 20 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 20 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 20 [hp_X] in 1 mL ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 20 [hp_X] in 1 mL NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM 20 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 20 [hp_X] in 1 mL PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT 20 [hp_X] in 1 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 20 [hp_X] in 1 mL QUERCUS ROBUR NUT (UNII: Q7MU1F4GLY) (QUERCUS ROBUR NUT - UNII:Q7MU1F4GLY) QUERCUS ROBUR NUT 20 [hp_X] in 1 mL KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT 20 [hp_X] in 1 mL VIPERA BERUS VENOM (UNII: 0ORO6NCA4M) (VIPERA BERUS VENOM - UNII:0ORO6NCA4M) VIPERA BERUS VENOM 21 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 11 [hp_X] in 1 mL SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 11 [hp_X] in 1 mL URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 11 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4845-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/31/2021 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-4845)
