Label: TESTOSTERONE (avena sativa, carduus marianus, damiana, galium aparine, hamamelis virginiana, hepar bovine, korean ginseng, nuphar luteum, orchitinum- bovine, populus tremuloides, testosterone, thuja occidentalis liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 43853-0005-1 - Packager: ProBLEN
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated April 7, 2017
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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WARNINGS:
Not for use on children. If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness. As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Tamper Evident: There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
TESTOSTERONE
avena sativa, carduus marianus, damiana, galium aparine, hamamelis virginiana, hepar bovine, korean ginseng, nuphar luteum, orchitinum (bovine), populus tremuloides, testosterone, thuja occidentalis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43853-0005 Route of Administration ORAL 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 1 [hp_X] in 1 mL SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED 1 [hp_X] in 1 mL TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG 1 [hp_X] in 1 mL GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE 3 [hp_X] in 1 mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X] in 1 mL BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER 6 [hp_X] in 1 mL ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG 1 [hp_X] in 1 mL NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT 2 [hp_X] in 1 mL BOS TAURUS TESTICLE (UNII: PR4RXL6G2H) (BOS TAURUS TESTICLE - UNII:PR4RXL6G2H) BOS TAURUS TESTICLE 6 [hp_X] in 1 mL POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID) POPULUS TREMULOIDES BARK 1 [hp_X] in 1 mL POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF 1 [hp_X] in 1 mL TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE 30 [hp_X] in 1 mL THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786) THUJA OCCIDENTALIS LEAF 200 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43853-0005-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/16/2013 Labeler - ProBLEN (838787161) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43853-0005) , api manufacture(43853-0005) , label(43853-0005) , pack(43853-0005)
