DETOX I- carduus marianus, chelidonium majus, cinchona officinalis, lycopodium clavatum, taraxacum officinale, veratrum album, a

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

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Active ingredient:
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE), CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN), CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB), LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479), TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375), VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z), AVENA
Available from:
Deseret Biologicals, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of symptoms related to improper breakdown and excretion of allergenic substances, including gastrointestinal, skin rashes, bowel disturbance and muscle cramping. For temporary relief of symptoms related to improper breakdown and excretion of allergenic substances, including gastrointestinal, skin rashes, bowel disturbance and muscle cramping.
Authorization status:
unapproved homeopathic
Authorization number:
43742-0061-1

DETOX I- carduus marianus, chelidonium majus, cinchona officinalis, lycopodium clavatum,

taraxacum officinale, veratrum album, avena sativa, cynara scolymus, methylcobalamin,

menadione, alpha-lipoicum acidum, hepar suis, colon (suis), duodenum (suis), gallbladder

(suis), intestine (suis), lymph node (suis), pancreas suis, thymus (suis), alpha-ketoglutaricum

acidum, cholesterinum, formicum acidum, glyoxal trimer dihydrate, histaminum

hydrochloricum, malic acid, natrum oxalaceticum, sulphur liquid

Deseret Biologicals, 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:

Carduus marianus 3X, Chelidonium majus 4X, Cinchona officinalis 4X, Lycopodium clavatum 4X,

Taraxacum officinale 4X, Veratrum album 4X, Avena sativa 6X, Cynara scolymus 6X, Methylcobalamin

6X, Menadione 6X, 8X, 30X, 200X, Alpha-Lipoicum acidum 8X, Hepar suis 8X, Colon (suis) 8X,

30X, 200X, Duodenum (suis) 8X, 30X, 200X, Gallbladder (suis) 8X, 30X, 200X, Intestine (suis) 8X,

30X, 200X, Lymph node (suis) 8X, 30X, 200X, Pancreas suis 8X, 30X, 200X, Thymus (suis), 8X, 30X,

200X, Alpha-Ketoglutaricum acidum 10X, Cholesterinum 10X, Formicum acidum 10X, Glyoxal trimer

dihydrate 10X, Histaminum hydrochloricum 10X, Malic acid 10X, Natrum oxalaceticum 10X, Sulphur

13X, Calcarea carbonica 28X, Oroticum acidum 7C, Morgan gaertner 30C, 200C, Morgan pure 30C,

200C.

INDICATIONS:

For temporary relief of symptoms related to improper breakdown and excretion of allergenic

substances, including gastrointestinal, skin rashes, bowel disturbance and muscle cramping.

WARNINGS:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right

away.

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

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician

for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right

away.

INDICATIONS:

For temporary relief of symptoms related to improper breakdown and excretion of allergenic

substances, including gastrointestinal, skin rashes, bowel disturbance and muscle cramping.

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Dr.

Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC 43742-0061-1

HOMEOPATHIC

DETOX I

1 FL OZ (30 ml)

DETOX I

carduus marianus, chelidonium majus, cinchona officinalis, lycopodium clavatum, taraxacum officinale, veratrum

album, avena sativa, cynara scolymus, methylcobalamin, menadione, alpha-lipoicum acidum, hepar suis, colon

(suis), duodenum (suis), gallbladder (suis), intestine (suis), lymph node (suis), pancreas suis, thymus (suis), alpha-

ketoglutaricum acidum, cholesterinum, formicum acidum, glyoxal trimer dihydrate, histaminum hydrochloricum,

malic acid, natrum oxalaceticum, sulphur liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43742-0 0 6 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SILYBUM MARIANUM SEED (UNII: U9 46 SH9 5EE) (SILYBUM MARIANUM SEED -

UNII:U9 46 SH9 5EE)

SILYBUM MARIANUM SEED

3 [hp_X]

in 1 mL

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

UNII:7E8 8 9 U5RNN)

CHELIDONIUM MAJUS

4 [hp_X]

in 1 mL

CINCHO NA O FFICINALIS BARK (UNII: S0 0 3A158 SB) (CINCHONA OFFICINALIS

BARK - UNII:S0 0 3A158 SB)

CINCHONA OFFICINALIS BARK

4 [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

4 [hp_X]

in 1 mL

TARAXACUM O FFICINALE (UNII: 39 9 8 1FM375) (TARAXACUM OFFICINALE -

UNII:39 9 8 1FM375)

TARAXACUM OFFICINALE

4 [hp_X]

in 1 mL

VERATRUM ALBUM RO O T (UNII: QNS6 W5US1Z) (VERATRUM ALBUM ROOT -

UNII:QNS6 W5US1Z)

VERATRUM ALBUM ROOT

4 [hp_X]

in 1 mL

AVENA SATIVA FLO WERING TO P (UNII: MA9 CQJ3F7F) (AVENA SATIVA

FLOWERING TOP - UNII:MA9 CQJ3F7F)

AVENA SATIVA FLOWERING

6 [hp_X]

in 1 mL

CYNARA SCO LYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF -

UNII:B71UA545DE)

CYNARA SCOLYMUS LEAF

6 [hp_X]

in 1 mL

METHYLCO BALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN -

UNII:BR1SN1JS2W)

METHYLCOBALAMIN

6 [hp_X]

in 1 mL

MENADIO NE (UNII: 723JX6 CXY5) (MENADIONE - UNII:723JX6 CXY5)

MENADIONE

6 [hp_X]

in 1 mL

.ALPHA.-LIPO IC ACID (UNII: 73Y7P0 K73Y) (.ALPHA.-LIPOIC ACID -

UNII:73Y7P0 K73Y)

.ALPHA.-LIPOIC ACID

8 [hp_X]

in 1 mL

PO RK LIVER (UNII: 6 EC70 6 HI7F) (PORK LIVER - UNII:6 EC70 6 HI7F)

PORK LIVER

8 [hp_X]

in 1 mL

SUS SCRO FA CO LO N (UNII: 9 4J255A0 UC) (SUS SCROFA COLON -

UNII:9 4J255A0 UC)

SUS SCROFA COLON

8 [hp_X]

in 1 mL

SUS SCRO FA DUO DENUM (UNII: P6 J2SFT8 0 O) (SUS SCROFA DUODENUM -

UNII:P6 J2SFT8 0 O )

SUS SCROFA DUODENUM

8 [hp_X]

in 1 mL

SUS SCRO FA GALLBLADDER (UNII: B6 A9 8 VOI9 I) (SUS SCROFA GALLBLADDER -

UNII:B6 A9 8 VO I9 I)

SUS SCROFA GALLBLADDER

8 [hp_X]

in 1 mL

PO RK INTESTINE (UNII: 40 GMI0 R6 0 L) (PORK INTESTINE - UNII:40 GMI0 R6 0 L)

PORK INTESTINE

8 [hp_X]

in 1 mL

SUS SCRO FA LYMPH (UNII: 33A7VYU29 L) (SUS SCROFA LYMPH -

UNII:33A7VYU29 L)

SUS SCROFA LYMPH

8 [hp_X]

in 1 mL

SUS SCRO FA PANCREAS (UNII: 9 Y3J336 2RY) (SUS SCROFA PANCREAS -

UNII:9 Y3J336 2RY)

SUS SCROFA PANCREAS

8 [hp_X]

in 1 mL

SUS SCRO FA THYMUS (UNII: 7B6 9 B0 BD6 2) (SUS SCROFA THYMUS -

UNII:7B6 9 B0 BD6 2)

SUS SCROFA THYMUS

8 [hp_X]

in 1 mL

.ALPHA.-KETO GLUTARIC ACID (UNII: 8 ID59 7Z8 2X) (.ALPHA.-KETOGLUTARIC

ACID - UNII:8 ID59 7Z8 2X)

.ALPHA.-KETOGLUTARIC ACID

10 [hp_X]

in 1 mL

CHO LESTERO L (UNII: 9 7C5T2UQ7J) (CHOLESTEROL - UNII:9 7C5T2UQ7J)

CHOLESTEROL

10 [hp_X]

in 1 mL

FO RMIC ACID (UNII: 0 YIW78 3RG1) (FORMIC ACID - UNII:0 YIW78 3RG1)

FORMIC ACID

10 [hp_X]

in 1 mL

GLYO XAL TRIMER DIHYDRATE (UNII: R6 GJS0 F9 NZ) (GLYOXAL -

UNII:50 NP6 JJ9 75)

GLYOXAL TRIMER DIHYDRATE

10 [hp_X]

in 1 mL

HISTAMINE DIHYDRO CHLO RIDE (UNII: 3POA0 Q6 44U) (HISTAMINE -

UNII:8 20 48 4N8 I3)

HISTAMINE DIHYDROCHLORIDE

10 [hp_X]

in 1 mL

MALIC ACID (UNII: 8 17L1N4CKP) (MALIC ACID - UNII:8 17L1N4CKP)

MALIC ACID

10 [hp_X]

in 1 mL

SO DIUM DIETHYL O XALACETATE (UNII: 6 CA0 25Y4FG) (DIETHYL OXALACETATE

- UNII:15S56 46 8 G7)

DIETHYL OXALACETATE

10 [hp_X]

in 1 mL

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

13 [hp_X]

in 1 mL

O YSTER SHELL CALCIUM CARBO NATE, CRUDE (UNII: 2E328 21G6 I) (OYSTER

SHELL CALCIUM CARBONATE, CRUDE - UNII:2E328 21G6 I)

OYSTER SHELL CALCIUM

CARBONATE, CRUDE

28 [hp_X]

in 1 mL

Deseret Biologicals, Inc.

O RO TIC ACID MO NO HYDRATE (UNII: 9 1532S0 2AO) (OROTIC ACID -

UNII:6 1H4T0 33E5)

OROTIC ACID MONOHYDRATE

7 [hp_C]

in 1 mL

SALMO NELLA ENTERICA SUBSP. ENTERICA SERO VAR ENTERITIDIS (UNII:

Y3V16 D4PV4) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS

- UNII:Y3V16 D4PV4)

SALMONELLA ENTERICA

SUBSP. ENTERICA SEROVAR

ENTERITIDIS

30 [hp_C]

in 1 mL

PRO TEUS MO RGANII (UNII: 56 X6 LID5ZY) (PROTEUS MORGANII -

UNII:56 X6 LID5ZY)

PROTEUS MORGANII

30 [hp_C]

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:43742-

0 0 6 1-1

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

Pro duc t

0 4/28 /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 6 /29 /20 12

0 9 /25/20 20

Labeler -

Deseret Biologicals, Inc. (940741853)

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(43742-0 0 6 1) , api manufacture(43742-0 0 6 1) , label(43742-0 0 6 1) , pack(43742-

0 0 6 1)

Revised: 4/2016

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