LEAKY GUT FORMULA (alfalfa, glycyrrhiza glabra, aloe, astacus fluviatilis, berberis aquifolium, lac defloratum, natrum carbonicu

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

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Active ingredient:
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD), GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H), ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9), ASTACUS ASTACUS (UNII: V0551986XQ) (ASTACUS ASTACUS - UNII:V0551986XQ), BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB), SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A), SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D), SUCROSE (UNII: C15
Available from:
Deseret Biologicals, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary relief of symptoms related to leaky gut syndrome such as fatigue, seasonal allergies, joint pain, occasional constipation, mental fogginess and occasional diarrhea.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration. For the temporary relief of symptoms related to leaky gut syndrome such as fatigue, seasonal allergies, joint pain, occasional constipation, mental fogginess and occasional diarrhea.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Authorization status:
unapproved homeopathic
Authorization number:
43742-1535-1

LEAKY GUT FORMULA- alfalfa, glycyrrhiza glabra, aloe, astacus fluviatilis, berberis

aquifolium, lac defloratum, natrum carbonicum, saccharum officinale, fel tauri, pancreas suis,

pancreatinum, fragaria vesca, antimonium crudum, carbo vegetabilis, euphorbium officinarum,

lycopodium clavatum, magnesia carbonica, zincum metallicum, colibacillinum cum natrum

muriaticum, proteus (vulgaris) 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:

Alfalfa 3X, Glycyrrhiza Glabra 3X, Aloe 4X, Astacus Fluviatilis 6X, Berberis Aquifolium 6X, Lac

Defloratum 6X, Natrum Carbonicum 6X, Saccharum Officinale 6X, Fel Tauri 8X, Pancreas Suis 8X,

Pancreatinum 8X, Fragaria Vesca 9X, Antimonium Crudum 12X, Carbo Vegetabilis 12X, Euphorbium

Officinarum 12X, Lycopodium Clavatum 12X, Magnesia Carbonica 12X, Zincum Metallicum 12X,

Colibacillinum 15X, 30X, 60X, 100X, 200X, Proteus (Vulgaris) 15X, 30X, 60X, 100X, 200X.

HOMEOPATHIC INDICATIONS:

For the temporary relief of symptoms related to leaky gut syndrome such as fatigue, seasonal allergies,

joint pain, occasional constipation, mental fogginess and occasional diarrhea.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by

the Food and Drug Administration.

WARNINGS:

Keep out of reach of children. In case of overdose, contact a physician or a 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.

KEEP OUT OF REACH OF CHILDREN:

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

right away.

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.

HOMEOPATHIC INDICATIONS:

For the temporary relief of symptoms related to leaky gut syndrome such as fatigue, seasonal allergies,

joint pain, occasional constipation, mental fogginess and occasional diarrhea.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by

the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC 43742-1535-1

HOMEOPATHIC

LEAKY GUT

FORMULA

1 FL OZ (30 ml)

LEAKY GUT FORMULA

alfalfa, glycyrrhiza glabra, aloe, astacus fluviatilis, berberis aquifolium, lac defloratum, natrum carbonicum,

saccharum officinale, fel tauri, pancreas suis, pancreatinum, fragaria vesca, antimonium crudum, carbo vegetabilis,

euphorbium officinarum, lycopodium clavatum, magnesia carbonica, zincum metallicum, colibacillinum cum natrum

muriaticum, proteus (vulgaris) liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43742-1535

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALFALFA (UNII: DJO9 34BRBD) (ALFALFA - UNII:DJO9 34BRBD)

ALFALFA

3 [hp_X]

in 1 mL

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H) (GLYCYRRHIZA GLABRA -

UNII:278 8 Z9 758 H)

GLYCYRRHIZA GLABRA

3 [hp_X]

in 1 mL

ALO E (UNII: V5VD430 YW9 ) (ALOE - UNII:V5VD430 YW9 )

ALOE

4 [hp_X]

in 1 mL

ASTACUS ASTACUS (UNII: V0 5519 8 6 XQ) (ASTACUS ASTACUS - UNII:V0 5519 8 6 XQ)

ASTACUS ASTACUS

6 [hp_X]

in 1 mL

BERBERIS AQ UIFO LIUM RO O T BARK (UNII: VZJ9 F3C3SB) (BERBERIS AQUIFOLIUM

ROOT BARK - UNII:VZJ9 F3C3SB)

BERBERIS AQUIFOLIUM

ROOT BARK

6 [hp_X]

in 1 mL

SKIM MILK (UNII: 6 A0 0 1Y4M5A) (SKIM MILK - UNII:6 A0 0 1Y4M5A)

SKIM MILK

6 [hp_X]

in 1 mL

SO DIUM CARBO NATE (UNII: 45P326 1C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)

SODIUM CARBONATE

6 [hp_X]

in 1 mL

SUCRO SE (UNII: C151H8 M554) (SUCROSE - UNII:C151H8 M554)

SUCROSE

6 [hp_X]

in 1 mL

BO S TAURUS BILE (UNII: ET36 51ZLOU) (BOS TAURUS BILE - UNII:ET36 51ZLOU)

BOS TAURUS BILE

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

PANCRELIPASE (UNII: FQ3DRG0 N5K) (PANCRELIPASE LIPASE - UNII:8 MYC339 32O)

PANCRELIPASE LIPASE

8 [hp_X]

in 1 mL

ALPINE STRAWBERRY (UNII: CG6 IX3GCMU) (ALPINE STRAWBERRY -

UNII:CG6 IX3GCMU)

ALPINE STRAWBERRY

9 [hp_X]

in 1 mL

ANTIMO NY TRISULFIDE (UNII: F79 0 59 A38 U) (ANTIMONY TRISULFIDE -

UNII:F79 0 59 A38 U)

ANTIMONY TRISULFIDE

12 [hp_X]

in 1 mL

ACTIVATED CHARCO AL (UNII: 2P3VWU3H10 ) (ACTIVATED CHARCOAL -

UNII:2P3VWU3H10 )

ACTIVATED CHARCOAL

12 [hp_X]

in 1 mL

EUPHO RBIA RESINIFERA RESIN (UNII: 1TI1O9 0 28 K) (EUPHORBIA RESINIFERA RESIN -

UNII:1TI1O 9 0 28 K)

EUPHORBIA RESINIFERA

RESIN

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

MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA) (CARBONATE ION -

UNII:7UJQ5OPE7D)

MAGNESIUM CARBONATE

12 [hp_X]

in 1 mL

ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)

ZINC

12 [hp_X]

in 1 mL

ESCHERICHIA CO LI (UNII: 514B9 K0 L10 ) (ESCHERICHIA COLI - UNII:514B9 K0 L10 )

ESCHERICHIA COLI

15 [hp_X]

in 1 mL

PRO TEUS VULGARIS (UNII: 11T9 HCO30 O) (PROTEUS VULGARIS - UNII:11T9 HCO30 O)

PROTEUS VULGARIS

15 [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:43742-

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

0 8 /22/20 19

Deseret Biologicals, Inc.

1

1535-1

Pro duc t

0 8 /22/20 19

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 8 /22/20 19

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(43742-1535) , api manufacture(43742-1535) , label(43742-1535) , pack(43742-

1535)

Revised: 8/2019

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