MALE TONICITY- american ginseng, arnica montana, turnera diffusa leafy twig, herring sperm dna, galium aparine, hamamelis virginiana root bark/stem bark, pork liver, cervus elaphus horn oil, ovis aries testicle, phosphoric acid, sus scrofa pituitary gland, thuja occidentalis leafy twig, thyroid, unspecified, tribulus terrestris, ginger spray 
Sunway Biotech LLC

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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Active Ingredients: Equal volumes of each ingredient: 

aralia quinquefolia 3X HPUS, arnica montana 3X HPUS, damiana 2X HPUS, DNA 6X HPUS, galium aparine 3X HPUS, hamamelis virginiana 3X HPUS, hepar suis 6X HPUS, oleum animale 8X HPUS, orchitinum 6X HPUS, phosphoricum acidum 200C HPUS, pituitarium posterium 8X HPUS, thuja occidentalis 3X HPUS, thyroidinum 12X HPUS, tribulus terrestris 2X HPUS, zingiber officinale 3X HPUS.

Male Tonicity

Energy Medicine with DNA

Homeopathic Fast-Acting Oral Spray

1.0 Fl Oz (30 ml)

Alcohol 9% v/v

Sunway Biotech

Scientifically Tested

Keep out of reach of children.

Directions: Adults Only: Spray twice under the tongue, three times a day. This bottle contains about a 1 month supply.

Warnings: Stop use and ask a doctor if symptoms persist more than 3 days, worsen, or if new symptoms occur.

Tamper Evident Seal: Do not use if seal around neck of bottle is broken or missing. The letters HPUS indicate that ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

Indications: Temporarily relieves symptoms of low male sexual energy, including: decrease in sexual desire; feelings of fatigue; decrease in performance and enjoyment.

Inactive Ingredients: alcohol 9% v/v, glycerin 10% v/v, purified water.

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MALE TONICITY 
american ginseng, arnica montana, turnera diffusa leafy twig, herring sperm dna, galium aparine, hamamelis virginiana root bark/stem bark, pork liver, cervus elaphus horn oil, ovis aries testicle, phosphoric acid, sus scrofa pituitary gland, thuja occidentalis leafy twig, thyroid, unspecified, tribulus terrestris, ginger spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27281-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG1.5 [hp_C]  in 1 mg
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1.5 [hp_C]  in 1 mg
TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG1 [hp_C]  in 1 mg
HERRING SPERM DNA (UNII: 51FI676N6F) (HERRING SPERM DNA - UNII:51FI676N6F) HERRING SPERM DNA3 [hp_C]  in 1 mg
GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE1.5 [hp_C]  in 1 mg
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1.5 [hp_C]  in 1 mg
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER3 [hp_C]  in 1 mg
CERVUS ELAPHUS HORN OIL (UNII: 7A7G0PQI12) (CERVUS ELAPHUS HORN OIL - UNII:7A7G0PQI12) CERVUS ELAPHUS HORN OIL4 [hp_C]  in 1 mg
OVIS ARIES TESTICLE (UNII: P873TP6713) (OVIS ARIES TESTICLE - UNII:P873TP6713) OVIS ARIES TESTICLE3 [hp_C]  in 1 mg
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID200 [hp_C]  in 1 mg
SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND4 [hp_C]  in 1 mg
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG1.5 [hp_C]  in 1 mg
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED6 [hp_C]  in 1 mg
TRIBULUS TERRESTRIS (UNII: 4X4HLN92OT) (TRIBULUS TERRESTRIS - UNII:4X4HLN92OT) TRIBULUS TERRESTRIS1 [hp_C]  in 1 mg
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER1.5 [hp_C]  in 1 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27281-010-9630 mg in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/08/2014
Labeler - Sunway Biotech LLC (019560802)
Establishment
NameAddressID/FEIBusiness Operations
Integra Health International, S.A. de C.V.589880301manufacture(27281-010)

Revised: 8/2014
Document Id: f7d294c4-23f8-488a-b795-d65ec1391cd7
Set id: 61179595-0ed2-4359-94e2-2066742bc5d6
Version: 1
Effective Time: 20140808
 
Sunway Biotech LLC