HYDRASTIS- hydrastis canadensis, lycopodium clavatum, ephedra vulgaris, mezereum, petroleum, pulsatilla, thuja occidentalis, spray

Hydrastis by

Drug Labeling and Warnings

Hydrastis by is a Homeopathic medication manufactured, distributed, or labeled by Marco Pharma International LLC., Nestmann Pharma GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Hydrastis Canadensis 4xHPUS

Lycopodium Clavatum 3xHPUS

Ephedra Vulgaris 3xHPUS

Mezereum 3xHPUS

Petroleum 8xHPUS

Pulsatilla 3xHPUS

Thuja Occidentalis 10xHPUS

The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

Purpose

For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.

Keep out of reach of children.

Suggested use

Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.

Warnings

Do not spray in eyes, mouth or ears.

If pregnant or breast-feeding, ask a health professional before use.

If swallowed, get medical help or contact Poison Control Center right away.

(Read Suggested Use Section)

Inactive Ingredients

Aqua Demineralisata; Aqua Hamamelidis; Alcohol 7.7% by volume,Glycerin and Thymol.

PRINCIPAL DISPLAY PANEL

Hydrastis.jpg

INGREDIENTS AND APPEARANCE

HYDRASTIS 
hydrastis canadensis, lycopodium clavatum, ephedra vulgaris, mezereum, petroleum, pulsatilla, thuja occidentalis, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60986-1013
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 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	3 [hp_X]  in 1 mL
EPHEDRA DISTACHYA FLOWERING TWIG (UNII: R55VQ87DP3) (EPHEDRA DISTACHYA FLOWERING TWIG - UNII:R55VQ87DP3)	EPHEDRA DISTACHYA FLOWERING TWIG	3 [hp_X]  in 1 mL
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV)	DAPHNE MEZEREUM BARK	3 [hp_X]  in 1 mL
KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E)	KEROSENE	8 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	3 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	10 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60986-1013-3	10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/28/2018
2	NDC: 60986-1013-4	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/1992

Labeler - Marco Pharma International LLC. (161994277)

Establishment
Name	Address	ID/FEI	Business Operations
Nestmann Pharma GmbH		323426262	manufacture(60986-1013)