MALE POWERHOUSE: Homeopathic Product Information

MALE POWERHOUSE- turnera diffusa leafy twig, dioscorea villosa tuber, ginkgo, saw palmetto, testosterone and withania somnifera root liquid
Infinite Therapies of Sarasota, Inc.

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.

ACTIVE INGREDIENTS:

INDICATIONS:

Support of sex drive, libido, and male performance.

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.

STORAGE:

Store in a cool, dry place.

DIRECTIONS:

5 to 10 drops orally up to 3 times daily as directed by your health care professional. Consult a physician for use in children under 18 years of age.

INACTIVE INGREDIENTS:

Demineralized Water, Ethanol 20%

KEEP OUT OF REACH OF CHILDREN.

​Keep out of reach of children. ​ In case of overdose, get medical halp or contact a Poison Control Center right away.

INDICATIONS:

Support of sex drive, libido, and male performance.

QUESTIONS:

MFD For: Infinite Therapies of Sarasota, Inc.

1188 N. Tamiami Trail, #205F

Sarasota, FL 34236

PACKAGE DISPLAY LABEL:

Infinite Therapies of Sarasota, Inc.

​Male PowerHouse

HOMEOPATHIC

1 fl. oz. (30 mL)

MALE POWERHOUSE damiana, dioscorea villosa, ginkgo biloba, sabal serrulata, testosterone, withania somnifera liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54005-0002 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TURNERA DIFFUSA LEAFY TWIG (TURNERA DIFFUSA LEAFY TWIG) TURNERA DIFFUSA LEAFY TWIG 3 [hp_X] in 1 mL DIOSCOREA VILLOSA TUBER (DIOSCOREA VILLOSA ROOT) DIOSCOREA VILLOSA TUBER 3 [hp_X] in 1 mL GINKGO (GINKGO) GINKGO 3 [hp_X] in 1 mL SAW PALMETTO (SAW PALMETTO) SAW PALMETTO 3 [hp_X] in 1 mL TESTOSTERONE (TESTOSTERONE) TESTOSTERONE 3 [hp_X] in 1 mL WITHANIA SOMNIFERA ROOT (WITHANIA SOMNIFERA ROOT) WITHANIA SOMNIFERA ROOT 3 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54005-0002-1 30 mL in 1 BOTTLE, DROPPER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/12/2013

Labeler — Infinite Therapies of Sarasota, Inc. (062334710)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (54005-0002), api manufacture (54005-0002), label (54005-0002), pack (54005-0002)

Revised: 08/2013 Infinite Therapies of Sarasota, Inc.