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NDC 63972-0015-01 8 Fungal Yeast Infection 30; 3; 3; 12; 3; 3; 5; 30; 30; 30; 3; 30; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Details

8 Fungal Yeast Infection 30; 3; 3; 12; 3; 3; 5; 30; 30; 30; 3; 30; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL

8 Fungal Yeast Infection is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by 21st Century Homeopathics, Inc. The primary component is APIS MELLIFERA; ASTRAGALUS PROPINQUUS ROOT; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; GENTIANA LUTEA ROOT; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA.

Product Information

NDC	63972-0015
Product ID	63972-015_6b32708d-f657-4811-a04b-f31f877fc107
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	8 Fungal Yeast Infection
Proprietary Name Suffix	n/a
Non-Proprietary Name	Astragalus Membranaceus, Berberis Vulgaris, Echinacea (Angustifolia), Gentiana Lutea, Hydrastis Canadensis, Phytolacca Decandra, Candida Albicans, Apis Mellifica, Calcarea Carbonica, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (Vulgaris) Sepia, T
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	30; 3; 3; 12; 3; 3; 5; 30; 30; 30; 3; 30; 30; 30
Active Ingredient Units	[hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Substance Name	APIS MELLIFERA; ASTRAGALUS PROPINQUUS ROOT; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; GENTIANA LUTEA ROOT; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA
Labeler Name	21st Century Homeopathics, Inc
Pharmaceutical Class	Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [P
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 63972-0015-01 (63972001501)

Pricing Information	N/A
NDC Package Code	63972-015-01
Billing NDC	63972001501
Package	120 mL in 1 BOTTLE (63972-015-01)
Marketing Start Date	2017-01-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 73bb3224-f650-4e14-bf83-cfc4f8fe4e99 Details

ACTIVE INGREDIENTS:

Astragalus Membranaceus 3X, 30C, Berberis Vulgaris 3X, 30C, Echinacea (Angustifolia) 3X, 30C, Gentiana Lutea 3X, 30C, Hydrastis Canadensis 5X, 30C, Phytolacca Decandra 3X, 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.

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 for your protection with a clear, full body seal. 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:

Manufactured for:

21st Century Homeopathics

Rosenberg, TX 77471 • (281) 344-0909

A subsidiary of Biotics Research Corporation

PACKAGE LABEL DISPLAY:

21ST CENTURY

HOMEOPATHICS

NDC #63972-015-01

HOMEOPATHIC REMEDY

Fungal Yeast Infection

Water Based

Formula

4 fl. oz.

(120 ml)

INGREDIENTS AND APPEARANCE

8 FUNGAL YEAST INFECTION

astragalus membranaceus, berberis vulgaris, echinacea (angustifolia), gentiana lutea, hydrastis canadensis, phytolacca decandra, 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:63972-015
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
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [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:63972-015-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2017	04/13/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/16/2017	04/13/2023

Labeler - 21st Century Homeopathics, Inc (006296353)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(63972-015) , api manufacture(63972-015) , label(63972-015) , pack(63972-015)

Revised: 12/2021

Document Id: 6b32708d-f657-4811-a04b-f31f877fc107

Set id: 73bb3224-f650-4e14-bf83-cfc4f8fe4e99

Version: 4

Effective Time: 20211223

Search by Drug Name or NDC

NDC 63972-0015-01 8 Fungal Yeast Infection 30; 3; 3; 12; 3; 3; 5; 30; 30; 30; 3; 30; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Details

8 Fungal Yeast Infection 30; 3; 3; 12; 3; 3; 5; 30; 30; 30; 3; 30; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL

Product Information

Package

Package Images

NDC 63972-0015-01 (63972001501)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 73bb3224-f650-4e14-bf83-cfc4f8fe4e99 Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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