Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID d3f89e4d-c3a0-4481-bf0e-0413993a8bc5
Route
ORAL
Published
Effective Date 2023-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia Whole (3 [hp_X]) Centella Asiatica Whole (6 [hp_X]) Saw Palmetto (8 [hp_X]) Handroanthus Impetiginosus Bark (12 [hp_X]) Thuja Occidentalis Leafy Twig (30 [hp_X]) Astragalus Propinquus Root (33 [hp_X]) Sus Scrofa Adrenal Gland Sus Scrofa Lymph Zinc Cation Juniperus Virginiana Twig Mercurius Solubilis Sodium Sulfate Anhydrous Sus Scrofa Testicle Sus Scrofa Prostate Pulsatilla Pratensis Whole Rhododendron Aureum Leaf Spongia Officinalis Skeleton, Roasted Calcium Cation Lycopodium Clavatum Spore Phosphorus Botulinum Toxin Type A Escherichia Coli Proteus Vulgaris Pseudomonas Aeruginosa Proteus Morganii Salmonella Enterica Enterica Serovar Typhi
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-08-29

Description

Echinacea 3X, Hydrocotyle Asiatica 3X, Sabal Serrulata 3X, Tabebuia Impetiginosa 3X, Thuja Occidentalis 3X, Astragalus Membranaceus 6X, Glandula Suprarenalis Suis 6X, Lymph Node 6X, Zincum Gluconicum 6X, Juniperus Virginiana 8X, Mercurius Solubilis 12X, Natrum Sulphuricum 12X, Orchitinum 12X, Prostate 12X, Pulsatilla 12X, Rhododendron Chrysanthum 12X, Spongia Tosta 12X, Calcarea Sulphurica 30X, Lycopodium Clavatum 30X, Phosphorus 30X, Botulinum 30X, 60X, Colibacillinum Cum Natrum Muriaticum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30x, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, 60X.


Medication Information

Description

Echinacea 3X, Hydrocotyle Asiatica 3X, Sabal Serrulata 3X, Tabebuia Impetiginosa 3X, Thuja Occidentalis 3X, Astragalus Membranaceus 6X, Glandula Suprarenalis Suis 6X, Lymph Node 6X, Zincum Gluconicum 6X, Juniperus Virginiana 8X, Mercurius Solubilis 12X, Natrum Sulphuricum 12X, Orchitinum 12X, Prostate 12X, Pulsatilla 12X, Rhododendron Chrysanthum 12X, Spongia Tosta 12X, Calcarea Sulphurica 30X, Lycopodium Clavatum 30X, Phosphorus 30X, Botulinum 30X, 60X, Colibacillinum Cum Natrum Muriaticum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30x, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, 60X.

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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

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 pain of the lower abdomen, yellow discharge from the urethra; urine passing slowly only in drops and painful urethral orifice after micturition.

Active Ingredients:

Echinacea 3X, Hydrocotyle Asiatica 3X, Sabal Serrulata 3X, Tabebuia Impetiginosa 3X, Thuja Occidentalis 3X, Astragalus Membranaceus 6X, Glandula Suprarenalis Suis 6X, Lymph Node 6X, Zincum Gluconicum 6X, Juniperus Virginiana 8X, Mercurius Solubilis 12X, Natrum Sulphuricum 12X, Orchitinum 12X, Prostate 12X, Pulsatilla 12X, Rhododendron Chrysanthum 12X, Spongia Tosta 12X, Calcarea Sulphurica 30X, Lycopodium Clavatum 30X, Phosphorus 30X, Botulinum 30X, 60X, Colibacillinum Cum Natrum Muriaticum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30x, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, 60X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

ANDROTOX

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

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

Indications: (INDICATIONS:)

For temporary relief of pain of the lower abdomen, yellow discharge from the urethra; urine passing slowly only in drops and painful urethral orifice after micturition.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea 3X, Hydrocotyle Asiatica 3X, Sabal Serrulata 3X, Tabebuia Impetiginosa 3X, Thuja Occidentalis 3X, Astragalus Membranaceus 6X, Glandula Suprarenalis Suis 6X, Lymph Node 6X, Zincum Gluconicum 6X, Juniperus Virginiana 8X, Mercurius Solubilis 12X, Natrum Sulphuricum 12X, Orchitinum 12X, Prostate 12X, Pulsatilla 12X, Rhododendron Chrysanthum 12X, Spongia Tosta 12X, Calcarea Sulphurica 30X, Lycopodium Clavatum 30X, Phosphorus 30X, Botulinum 30X, 60X, Colibacillinum Cum Natrum Muriaticum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30x, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, 60X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

ANDROTOX

HOMEOPATHIC

1 FL OZ (30 ml)

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.


Advanced Ingredient Data


Raw Label Data

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