Label: TESTOSTERONE- avena sativa, baryta carbonica, carduus mar, damiana, hamamelis virg, hepar, korean ginseng, nuphar, orchitinum, phosphoricum acidum, populus trem, sabal serulata, selenium metallicum, testosterone. liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 43853-0021-1 - Packager: ProBlen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CIII
- 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 October 5, 2020
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
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. In case of overdose, get medical help or contact a Poison Control Center right away.
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INGREDIENTS AND APPEARANCE
TESTOSTERONE
avena sativa, baryta carbonica, carduus mar, damiana, hamamelis virg, hepar, korean ginseng, nuphar, orchitinum, phosphoricum acidum, populus trem, sabal serulata, selenium metallicum, testosterone. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43853-0021 Route of Administration ORAL DEA Schedule CIII 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 30 mL BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE 8 [hp_X] in 30 mL MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE 1 [hp_X] in 30 mL TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG 1 [hp_X] in 30 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 30 mL PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER 6 [hp_X] in 30 mL ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG 1 [hp_X] in 30 mL NUPHAR LUTEA ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEA ROOT - UNII:714LIU3V6D) NUPHAR LUTEA ROOT 2 [hp_X] in 30 mL SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28) SUS SCROFA TESTICLE 6 [hp_X] in 30 mL PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 12 [hp_X] in 30 mL POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF 1 [hp_X] in 30 mL SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO 6 [hp_X] in 30 mL SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 12 [hp_X] in 30 mL TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE 30 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43853-0021-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/28/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/28/2017 Labeler - ProBlen (838787161)
