8 FUNGAL YEAST INFECTION- astragalus membranaceus, berberis vulgaris, echinacea (angustifolia), gentiana lutea, phytolacca decandra, hydrastis canadensis, candida albicans, apis mellifica, calcarea carbonica, lycopodium clavatum, mercurius solubilis, pulsatilla (vulgaris) sepia, thuja occidentalis liquid
Biotics Research Corporation

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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Drug Facts:

ACTIVE INGREDIENTS:

Astragalus Membranaceus 3X, 30C, Berberis Vulgaris 3X, 30C, Echinacea (Angustifolia) 3X, 30C, Gentiana Lutea 3X, 30C, Phytolacca Decandra 4X, 30C, Hydrastis Canadensis 5X, 30C, Candida Albicans 12X, 30X, Apis Mellifica 30C, Calcarea Carbonica 30C, Lycopodium Clavatum 30C, Mercurius Solubilis 30C, Pulsatilla (Vulgaris) 30C, Sepia 30C, Thuja Occidentalis 30C.

INDICATIONS:

For temporary relief of flatulence, bloating and rhinitis. Remedy #8 supports detoxification due to mycotic infections.

WARNINGS:

If symptoms persist or worsen, seek the advice of a healthcare professional.

Caution: Not recommended for pregnant or lactating women.

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

Tamper Seal: Sealed with an imprinted safety seal for your protection. Do not use if seal is missing or broken.

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:

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional. Consult a physician for use in children under 6 years of age.

INDICATIONS:

For temporary relief of flatulence, bloating and rhinitis. Remedy #8 supports detoxification due to mycotic infections.

INACTIVE INGREDIENTS:

Citric acid, Demineralized Water, Ethanol and Sodium benzoate.

QUESTIONS:

Distributed by

Biotics Research Corporation

Rosenberg, TX 77471 • (281) 344-0909

PACKAGE LABEL DISPLAY:

Biotics Research Corporation's

21ST CENTURY

HOMEOPATHICS

NDC #55146-008-01

HOMEOPATHIC REMEDY

Fungal Yeast Infection

Water Based

Formula

(2.36% Ethanol)

4 fl. oz.

(120 ml)

#8 Fungal Yeast Infection

8 FUNGAL YEAST INFECTION
astragalus membranaceus, berberis vulgaris, echinacea (angustifolia), gentiana lutea, phytolacca decandra, hydrastis canadensis, candida albicans, apis mellifica, calcarea carbonica, lycopodium clavatum, mercurius solubilis, pulsatilla (vulgaris) sepia, thuja occidentalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55146-008
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF) (ASTRAGALUS PROPINQUUS ROOT - UNII:922OP8YUPF)	ASTRAGALUS PROPINQUUS ROOT	3 [hp_X] in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	3 [hp_X] in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X] in 1 mL
GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS)	GENTIANA LUTEA ROOT	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X] in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	12 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	30 [hp_C] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_C] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C] in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	30 [hp_C] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_C] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_C] in 1 mL
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786)	THUJA OCCIDENTALIS LEAF	30 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55146-008-01	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/11/2019	04/13/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/11/2019	04/13/2023

Labeler - Biotics Research Corporation (092487347)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(55146-008) , api manufacture(55146-008) , label(55146-008) , pack(55146-008)

Revised: 12/2021

Document Id: dcbd6925-2b84-4e12-b6fc-18f4737c60e9

Set id: 1098effa-f60c-4550-9f2e-8dcab053b2e1

Version: 6

Effective Time: 20211223

Biotics Research Corporation