HYDRASTIS- hydrastis canadensis, lycopodium clavatum, ephedra vulgaris, mezereum, petroleum, pulsatilla, thuja occidentalis, spray
Marco Pharma International LLC.

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.

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Drug Facts

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.

Hydrastis_N1214

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60986-1013-3	10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/28/2018	12/10/2021
2	NDC:60986-1013-4	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/28/2018	12/10/2021
3	NDC:60986-1013-5	20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/10/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/1992	12/31/2023

Labeler - Marco Pharma International LLC. (161994277)

Registrant - Marco Pharma International LLC. (161994277)

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

Revised: 1/2024

Document Id: 0e7705bd-15fc-d906-e063-6394a90a2ee4

Set id: 6cd912eb-6f98-45c7-a81e-248bb112ab1e

Version: 6

Effective Time: 20240108

Marco Pharma International LLC.