MALE BALANCE (avena sativa, hepar suis, orchitinum (suis), testosterone, agnus castus, damiana, ginkgo biloba, hypothalamus (suis), lycopodium clabatum, spermidine, spermine, human growth hormone, epimedium grandiflorum, serotonin- hydrochloride liquid

Male Balance by

Drug Labeling and Warnings

Male Balance by is a Homeopathic medication manufactured, distributed, or labeled by Energique,Inc., Apotheca Company, Apotheca Comapny. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

(in each spray): 6.66% of Agnus Castus 12X, Avena Sativa 6X, Damiana 12X, Epimedium Grandiflorum 30C, Ginkgo Biloba 12X, Hepar Suis 6X, Human Growth Hormone 26X, Hypothalamus (Suis) 12X, Lycopodium Clabatum 12X, Orchitinum (Suis) 6X, Serotonin (Hydrochloride) 30C, Spermidine 12X, 30X, Spermine 12X, 30X; 0.10% of Testosterone 6X.

INDICATIONS:

For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

If pregnant or breast-feeding, ask a health 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 a cool, dry place.

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:

Two sprays twice daily. Hold in mouth for 30 seconds.

INDICATIONS:

For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Citric Acid, Demineralized Water, Glycerin, Sodium Benzoate.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579  800-869-8078

PACKAGE LABEL DISPLAY

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

MALE BALANCE

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

MALE BALANCE 
avena sativa, hepar suis, orchitinum (suis), testosterone, agnus castus, damiana, ginkgo biloba, hypothalamus (suis), lycopodium clabatum, spermidine, spermine, human growth hormone, epimedium grandiflorum, serotonin (hydrochloride) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0126
Route of Administration	ORAL	DEA Schedule	CIII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	6 [hp_X]  in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X]  in 1 mL
SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28)	SUS SCROFA TESTICLE	6 [hp_X]  in 1 mL
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE	6 [hp_X]  in 1 mL
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	12 [hp_X]  in 1 mL
TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ)	TURNERA DIFFUSA LEAFY TWIG	12 [hp_X]  in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	12 [hp_X]  in 1 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 1 mL
SPERMIDINE (UNII: U87FK77H25) (SPERMIDINE - UNII:U87FK77H25)	SPERMIDINE	12 [hp_X]  in 1 mL
SPERMINE (UNII: 2FZ7Y3VOQX) (SPERMINE - UNII:2FZ7Y3VOQX)	SPERMINE	12 [hp_X]  in 1 mL
SOMATROPIN (UNII: NQX9KB6PCL) (SOMATROPIN - UNII:NQX9KB6PCL)	SOMATROPIN	26 [hp_X]  in 1 mL
EPIMEDIUM GRANDIFLORUM TOP (UNII: 137PC46F89) (EPIMEDIUM GRANDIFLORUM TOP - UNII:137PC46F89)	EPIMEDIUM GRANDIFLORUM TOP	30 [hp_C]  in 1 mL
SEROTONIN HYDROCHLORIDE (UNII: GKN429M9VS) (SEROTONIN - UNII:333DO1RDJY)	SEROTONIN HYDROCHLORIDE	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44911-0126-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/15/2014

Labeler - Energique,Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Comapny		844330915	manufacture(44911-0126) , api manufacture(44911-0126) , label(44911-0126) , pack(44911-0126)