NDC | 58264-0223-1 |
Set ID | db4f1434-c26b-4526-95d1-00099bf77839 |
Category | HUMAN OTC DRUG LABEL |
Packager | DNA Labs, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
- INDICATIONS
- INGREDIENTS
- SUGGESTED DOSAGE
- SPL UNCLASSIFIED SECTION
- Warnings
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
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INGREDIENTS AND APPEARANCE
N-25
serenoa repens whole, agathosma crenulata whole, chimaphila umbellata, elymus repens whole, selenium, and bos taurus prostate gland solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58264-0223 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SERENOA REPENS WHOLE (UNII: 487DXM62F2) (SERENOA REPENS WHOLE - UNII:487DXM62F2) SERENOA REPENS WHOLE 2 [hp_X] in 1 mL AGATHOSMA CRENULATA WHOLE (UNII: B6642J883V) (AGATHOSMA CRENULATA WHOLE - UNII:B6642J883V) AGATHOSMA CRENULATA WHOLE 2 [hp_X] in 1 mL Chimaphila umbellata (UNII: WCK21A9W9J) (Chimaphila umbellata - UNII:WCK21A9W9J) Chimaphila umbellata 3 [hp_X] in 1 mL ELYMUS REPENS WHOLE (UNII: BE5076899X) (ELYMUS REPENS WHOLE - UNII:BE5076899X) ELYMUS REPENS WHOLE 3 [hp_X] in 1 mL SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 6 [hp_X] in 1 mL BOS TAURUS PROSTATE GLAND (UNII: 1P66FXU2MW) (BOS TAURUS PROSTATE GLAND - UNII:1P66FXU2MW) BOS TAURUS PROSTATE GLAND 200 [hp_X] in 1 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:58264-0223-1 29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/01/1990 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 01/01/1990 Labeler - DNA Labs, Inc. (031784339)