Male Tonicity

Manufacturer: Integra Health International, S.A. de C.V.
Effective date: 2014-08-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:53

Label at a glance#

ProductMale Tonicity

Active ingredientAMERICAN 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

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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 & USAGE SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55138-013-01	2019-11-27	C162847	48780-1	9855e2a2-3e2b-60a7-e053-dbdaa90a05bd	5a01765f-4951-4f8a-aa3f-9fe632f31b70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55138-013-01	Male Tonicity	30 mg in 1 BOTTLE, SPRAY	SPRAY	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55138-013	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 [INTEGRA HEALTH INTERNATIONAL, S.A. DE C.V.]	1	Legacy NDC, 1 package rows	20140808_5a01765f-4951-4f8a-aa3f-9fe632f31b70.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AMERICAN GINSENG	ACTIVE INGREDIENT	8W75VCV53Q	1
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	1
CERVUS ELAPHUS HORN OIL	ACTIVE INGREDIENT	7A7G0PQI12	1
GALIUM APARINE	ACTIVE INGREDIENT	Z4B6561488	1
GINGER	ACTIVE INGREDIENT	C5529G5JPQ	1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	ACTIVE INGREDIENT	T7S323PKJS	1
HERRING SPERM DNA	ACTIVE INGREDIENT	51FI676N6F	1
OVIS ARIES TESTICLE	ACTIVE INGREDIENT	P873TP6713	1
PHOSPHORIC ACID	ACTIVE INGREDIENT	E4GA8884NN	1
PORK LIVER	ACTIVE INGREDIENT	6EC706HI7F	1
SUS SCROFA PITUITARY GLAND	ACTIVE INGREDIENT	E8S87O660T	1
THUJA OCCIDENTALIS LEAFY TWIG	ACTIVE INGREDIENT	1NT28V9397	1
THYROID, UNSPECIFIED	ACTIVE INGREDIENT	0B4FDL9I6P	1
TRIBULUS TERRESTRIS	ACTIVE INGREDIENT	4X4HLN92OT	1
TURNERA DIFFUSA LEAFY TWIG	ACTIVE INGREDIENT	RQ2CFA7WWJ	1
AMERICAN GINSENG	ACTIVE MOIETY	8W75VCV53Q	1
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	1
CERVUS ELAPHUS HORN OIL	ACTIVE MOIETY	7A7G0PQI12	1
GALIUM APARINE	ACTIVE MOIETY	Z4B6561488	1
GINGER	ACTIVE MOIETY	C5529G5JPQ	1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	ACTIVE MOIETY	T7S323PKJS	1
HERRING SPERM DNA	ACTIVE MOIETY	51FI676N6F	1
OVIS ARIES TESTICLE	ACTIVE MOIETY	P873TP6713	1
PHOSPHORIC ACID	ACTIVE MOIETY	E4GA8884NN	1
PORK LIVER	ACTIVE MOIETY	6EC706HI7F	1
SUS SCROFA PITUITARY GLAND	ACTIVE MOIETY	E8S87O660T	1
THUJA OCCIDENTALIS LEAFY TWIG	ACTIVE MOIETY	1NT28V9397	1
THYROID, UNSPECIFIED	ACTIVE MOIETY	0B4FDL9I6P	1
TRIBULUS TERRESTRIS	ACTIVE MOIETY	4X4HLN92OT	1
TURNERA DIFFUSA LEAFY TWIG	ACTIVE MOIETY	RQ2CFA7WWJ	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

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
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
ALCOHOL
GLYCERIN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55138-013	55138-013-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMERICAN GINSENG	8W75VCV53Q	ACTIB
ARNICA MONTANA	O80TY208ZW	ACTIB
TURNERA DIFFUSA LEAFY TWIG	RQ2CFA7WWJ	ACTIB
HERRING SPERM DNA	51FI676N6F	ACTIB
GALIUM APARINE	Z4B6561488	ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	T7S323PKJS	ACTIB
PORK LIVER	6EC706HI7F	ACTIB
CERVUS ELAPHUS HORN OIL	7A7G0PQI12	ACTIB
OVIS ARIES TESTICLE	P873TP6713	ACTIB
PHOSPHORIC ACID	E4GA8884NN	ACTIB
SUS SCROFA PITUITARY GLAND	E8S87O660T	ACTIB
THUJA OCCIDENTALIS LEAFY TWIG	1NT28V9397	ACTIB
THYROID, UNSPECIFIED	0B4FDL9I6P	ACTIB
TRIBULUS TERRESTRIS	4X4HLN92OT	ACTIB
GINGER	C5529G5JPQ	ACTIB
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 134 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0d9732a5-d779-4afa-bdeb-f2d261ab474b			5a01765f-4951-4f8a-aa3f-9fe632f31b70	2014-08-08	Warnings	Exact identifier spl id: 0d9732a5-d779-4afa-bdeb-f2d261ab474b spl set id: 5a01765f-4951-4f8a-aa3f-9fe632f31b70

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.