Label: HYDRASTIS- hydrastis canadensis, lycopodium clavatum, ephedra vulgaris, mezereum, petroleum, pulsatilla, thuja occidentalis spray
- NDC Code(s): 60986-1015-5
- Packager: Marco Pharma International LLC
- 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 December 6, 2023
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
HYDRASTIS
hydrastis canadensis, lycopodium clavatum, ephedra vulgaris, mezereum, petroleum, pulsatilla, thuja occidentalis sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60986-1015 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 4 [hp_X] in 100 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 3 [hp_X] in 100 mL EPHEDRA DISTACHYA FLOWERING TWIG (UNII: R55VQ87DP3) (EPHEDRA DISTACHYA FLOWERING TWIG - UNII:R55VQ87DP3) EPHEDRA DISTACHYA FLOWERING TWIG 3 [hp_X] in 100 mL DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK 3 [hp_X] in 100 mL KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE 8 [hp_X] in 100 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 3 [hp_X] in 100 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X] in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) GLYCERIN (UNII: PDC6A3C0OX) THYMOL (UNII: 3J50XA376E) HYDROGEN PEROXIDE (UNII: BBX060AN9V) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60986-1015-5 20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/02/2023 Labeler - Marco Pharma International LLC (161994277) Registrant - Marco Pharma International LLC (161994277) Establishment Name Address ID/FEI Business Operations Nestmann Pharma GmbH 323426262 manufacture(60986-1015)