Varicose 2240L-Dis

Drug Labeling and Warnings

Drug Details [pdf]

VARICOSE VEINS- elaps corallinus, crotalus horridus, bryonia, calc. fluor., carduus mar., cholesterinum, cinchona, digitalis, hamamelis, hydrofluoricum acidum, lachesis, lycopodium, naja, pulsatilla, vipera berus, zinc. met., aesculus hipp., echinacea 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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Varicose 2240L-Dis

INDICATIONS & USAGE SECTION

Varicose Veins   Formulated for associated symptoms such as visible, enlarged veins, swelling, discoloration, pain, stinging and heaviness in the extremities.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.   Adults, take 6 drops orally 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, Crotalus horridus 15x, Bryonia 10x, Calc. fluor. 10x, Carduus mar. 10x, Cholesterinum 10x, Cinchona 10x, Digitalis 10x, Hamamelis 10x, Hydrofluoricum acidum 10x, Lachesis 10x, Lycopodium 10x, Naja 10x, Pulsatilla 10x, Vipera berus 10x, Zinc. met. 10x, Aesculus hipp. 3x, Echinacea 3x, Hamamelis 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as visible, enlarged veins, swelling, discoloration, pain, stinging and heaviness in the extremities.

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

VARICOSE VEINS 
elaps corallinus, crotalus horridus, bryonia, calc. fluor., carduus mar., cholesterinum, cinchona, digitalis, hamamelis, hydrofluoricum acidum, lachesis, lycopodium, naja, pulsatilla, vipera berus, zinc. met., aesculus hipp., echinacea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-2240
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	30 [hp_X]  in 1 mL
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956)	CROTALUS HORRIDUS HORRIDUS VENOM	15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X]  in 1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	10 [hp_X]  in 1 mL
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE)	SILYBUM MARIANUM SEED	10 [hp_X]  in 1 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J)	CHOLESTEROL	10 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	10 [hp_X]  in 1 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	10 [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	10 [hp_X]  in 1 mL
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	10 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	10 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	10 [hp_X]  in 1 mL
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)	NAJA NAJA VENOM	10 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	10 [hp_X]  in 1 mL
VIPERA BERUS VENOM (UNII: 0ORO6NCA4M) (VIPERA BERUS VENOM - UNII:0ORO6NCA4M)	VIPERA BERUS VENOM	10 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	10 [hp_X]  in 1 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	3 [hp_X]  in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-2240-1	29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019
2	NDC: 55714-2240-2	59.14 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019
3	NDC: 55714-2240-0	0.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011	01/31/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-2240)

Revised: 1/2019

Document Id: 90a819da-bddd-00e8-e053-2995a90a99e3

34390-5

Set id: 45d1625d-39bf-dbbc-0272-02313d720485

Version: 3

Effective Time: 20190131

 

Newton Laboratories, Inc.