NDC | 58264-0016-1 |
Set ID | 4784ddc2-c308-4092-a01f-ea2b2954a888 |
Category | HUMAN OTC DRUG LABEL |
Packager | DNA Labs, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
- INDICATIONS
- INGREDIENTS
- SUGGESTED DOSAGE
- STORAGE AND HANDLING
- Warnings
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
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INGREDIENTS AND APPEARANCE
D-16
black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58264-0016 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 4 [hp_X] in 1 mL IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 2 [hp_X] in 1 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 2 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X] in 1 mL Spigelia anthelmia (UNII: WYT05213GE) (Spigelia anthelmia - UNII:WYT05213GE) Spigelia anthelmia 4 [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:58264-0016-1 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)