EDEMAFORCE- cactus grandiflorus, calendula officinalis, dulcamara, leptandra virginica, solidago virgaurea, convallaria majalis,

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK), CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ), SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N), VERONICASTRUM VIRGINICUM ROOT (UNII: M2O62YTN42) (CULVER'S ROOT - UNII:M2O62YTN42), SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50), CONVALLARIA MAJALIS (UNI
Available from:
BioActive Nutritional, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of symptoms due to swelling of the extremities. For temporary relief of symptoms due to swelling of the extremities.
Authorization status:
unapproved homeopathic
Authorization number:
43857-0395-1

EDEMAFORCE- cactus grandiflorus, calendula officinalis, dulcamara, leptandra virginica,

solidago virgaurea, convallaria majalis, apis mellifica, arnica montana, berberis vulgaris, bryonia

(alba), chelidonium majus, lycopodium clavatum, plumbum metallicum, sambucus nigra liquid

BioActive Nutritional, 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.

----------

Drug Facts:

ACTIVE INGREDIENTS:

Cactus Grandiflorus 3X, Calendula Officinalis 3X, Dulcamara 3X, Leptandra Virginica 3X, Solidago

Virgaurea 3X, Convallaria Majalis 4X, Apis Mellifica 12X, Arnica Montana 12X, Berberis Vulgaris

12X, Bryonia (Alba) 12X, Chelidonium Majus 12X, Lycopodium Clavatum 12X, Plumbum Metallicum

12X, Sambucus Nigra 12X.

INDICATIONS:

For temporary relief of symptoms due to swelling of the extremities.

WARNINGS:

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of symptoms due to swelling of the extremities.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

EDEMAFORCE

HOMEOPATHIC

1 FL OZ (30 ml)

EDEMAFORCE

cactus grandiflorus, calendula officinalis, dulcamara, leptandra virginica, solidago virgaurea, convallaria majalis,

apis mellifica, arnica montana, berberis vulgaris, bryonia (alba), chelidonium majus, lycopodium clavatum, plumbum

metallicum, sambucus nigra liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:438 57-0 39 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SELENICEREUS GRANDIFLO RUS STEM (UNII: 7114SV0 MYK) (SELENICEREUS

GRANDIFLORUS STEM - UNII:7114SV0 MYK)

SELENICEREUS

GRANDIFLORUS STEM

3 [hp_X]

in 1 mL

CALENDULA O FFICINALIS FLO WERING TO P (UNII: 18 E7415PXQ) (CALENDULA

OFFICINALIS FLOWERING TOP - UNII:18 E7415PXQ)

CALENDULA OFFICINALIS

FLOWERING TOP

3 [hp_X]

in 1 mL

SO LANUM DULCAMARA TO P (UNII: KPS1B116 2N) (SOLANUM DULCAMARA TOP -

UNII:KPS1B116 2N)

SOLANUM DULCAMARA

3 [hp_X]

in 1 mL

VERO NICASTRUM VIRGINICUM RO O T (UNII: M2O6 2YTN42) (CULVER'S ROOT -

UNII:M2O6 2YTN42)

VERONICASTRUM

VIRGINICUM ROOT

3 [hp_X]

in 1 mL

SO LIDAGO VIRGAUREA FLO WERING TO P (UNII: 540 5K23S50 ) (SOLIDAGO

SOLIDAGO VIRGAUREA

3 [hp_X]

BioActive Nutritional, Inc.

VIRGAUREA FLOWERING TOP - UNII:540 5K23S50 )

FLOWERING TOP

in 1 mL

CO NVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS -

UNII:QHH4HVF5QE)

CONVALLARIA MAJALIS

4 [hp_X]

in 1 mL

APIS MELLIFERA (UNII: 7S8 2P3R43Z) (APIS MELLIFERA - UNII:7S8 2P3R43Z)

APIS MELLIFERA

12 [hp_X]

in 1 mL

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

12 [hp_X]

in 1 mL

BERBERIS VULGARIS RO O T BARK (UNII: 1TH8 Q20 J0 U) (BERBERIS VULGARIS

ROOT BARK - UNII:1TH8 Q20 J0 U)

BERBERIS VULGARIS ROOT

BARK

12 [hp_X]

in 1 mL

BRYO NIA ALBA RO O T (UNII: T7J0 46 YI2B) (BRYONIA ALBA ROOT -

UNII:T7J0 46 YI2B)

BRYONIA ALBA ROOT

12 [hp_X]

in 1 mL

CHELIDO NIUM MAJUS (UNII: 7E8 8 9 U5RNN) (CHELIDONIUM MAJUS -

UNII:7E8 8 9 U5RNN)

CHELIDONIUM MAJUS

12 [hp_X]

in 1 mL

LYCO PO DIUM CLAVATUM SPO RE (UNII: C8 8 X29 Y479 ) (LYCOPODIUM CLAVATUM

SPORE - UNII:C8 8 X29 Y479 )

LYCOPODIUM CLAVATUM

SPORE

12 [hp_X]

in 1 mL

LEAD (UNII: 2P29 9 V78 4P) (LEAD - UNII:2P29 9 V78 4P)

LEAD

12 [hp_X]

in 1 mL

SAMBUCUS NIGRA FLO WERING TO P (UNII: CT0 3BSA18 U) (SAMBUCUS NIGRA

FLOWERING TOP - UNII:CT0 3BSA18 U)

SAMBUCUS NIGRA

FLOWERING TOP

12 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:438 57-

0 39 5-1

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/31/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 5/31/20 16

Labeler -

BioActive Nutritional, Inc. (624980496)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(438 57-0 39 5) , api manufacture(438 57-0 39 5) , label(438 57-0 39 5) , pack(438 57-

0 39 5)

Revised: 5/2016

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