| NDC | 55138-013-01 |
| Set ID | 5a01765f-4951-4f8a-aa3f-9fe632f31b70 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Integra Health International, S.A. de C.V. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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ACTIVE INGREDIENT
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.
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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WARNINGS
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
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 sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55138-013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG 1.5 [hp_C] in 1 mg ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 1.5 [hp_C] in 1 mg TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG 1 [hp_C] in 1 mg HERRING SPERM DNA (UNII: 51FI676N6F) (HERRING SPERM DNA - UNII:51FI676N6F) HERRING SPERM DNA 3 [hp_C] in 1 mg GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE 1.5 [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 BARK 1.5 [hp_C] in 1 mg PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER 3 [hp_C] in 1 mg CERVUS ELAPHUS HORN OIL (UNII: 7A7G0PQI12) (CERVUS ELAPHUS HORN OIL - UNII:7A7G0PQI12) CERVUS ELAPHUS HORN OIL 4 [hp_C] in 1 mg OVIS ARIES TESTICLE (UNII: P873TP6713) (OVIS ARIES TESTICLE - UNII:P873TP6713) OVIS ARIES TESTICLE 3 [hp_C] in 1 mg PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 200 [hp_C] in 1 mg SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND 4 [hp_C] in 1 mg THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 1.5 [hp_C] in 1 mg THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED 6 [hp_C] in 1 mg TRIBULUS TERRESTRIS (UNII: 4X4HLN92OT) (TRIBULUS TERRESTRIS - UNII:4X4HLN92OT) TRIBULUS TERRESTRIS 1 [hp_C] in 1 mg GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 1.5 [hp_C] in 1 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55138-013-01 30 mg in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/08/2014 Labeler - Integra Health International, S.A. de C.V. (589880301) Establishment Name Address ID/FEI Business Operations Integra Health International, S.A. de C.V. 589880301 manufacture(55138-013)
