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 
Newton Laboratories, Inc.

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.

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Hemorrhoids 4845L

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

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

Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.

package 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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-4845
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICRURUS CORALLINUS VENOM (UNII: V0S6H36980) (MICRURUS CORALLINUS VENOM - UNII:V0S6H36980) MICRURUS CORALLINUS VENOM35 [hp_X]  in 1 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT20 [hp_X]  in 1 mL
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE20 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE20 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT20 [hp_X]  in 1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE20 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM20 [hp_X]  in 1 mL
COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT20 [hp_X]  in 1 mL
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM20 [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 BARK20 [hp_X]  in 1 mL
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM20 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM20 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE20 [hp_X]  in 1 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM20 [hp_X]  in 1 mL
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM20 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED20 [hp_X]  in 1 mL
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT20 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR20 [hp_X]  in 1 mL
QUERCUS ROBUR NUT (UNII: Q7MU1F4GLY) (QUERCUS ROBUR NUT - UNII:Q7MU1F4GLY) QUERCUS ROBUR NUT20 [hp_X]  in 1 mL
KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT20 [hp_X]  in 1 mL
VIPERA BERUS VENOM (UNII: 0ORO6NCA4M) (VIPERA BERUS VENOM - UNII:0ORO6NCA4M) VIPERA BERUS VENOM21 [hp_X]  in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED11 [hp_X]  in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP11 [hp_X]  in 1 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS11 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4845-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/31/2021
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-4845)

Revised: 7/2021
Document Id: c6f30a38-ec25-7129-e053-2995a90abbc5
Set id: c6f30a27-ae7f-2574-e053-2995a90a9102
Version: 1
Effective Time: 20210712
 
Newton Laboratories, Inc.