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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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 States.

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

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.

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

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

Keep out of reach of children.

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

N10216

HYDRASTIS 
hydrastis canadensis, lycopodium clavatum, ephedra vulgaris, mezereum, petroleum, pulsatilla, thuja occidentalis spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60986-1015
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL4 [hp_X]  in 100 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE3 [hp_X]  in 100 mL
EPHEDRA DISTACHYA FLOWERING TWIG (UNII: R55VQ87DP3) (EPHEDRA DISTACHYA FLOWERING TWIG - UNII:R55VQ87DP3) EPHEDRA DISTACHYA FLOWERING TWIG3 [hp_X]  in 100 mL
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK3 [hp_X]  in 100 mL
KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE8 [hp_X]  in 100 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS3 [hp_X]  in 100 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
GLYCERIN (UNII: PDC6A3C0OX)  
THYMOL (UNII: 3J50XA376E)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60986-1015-520 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/02/2023
Labeler - Marco Pharma International LLC (161994277)
Registrant - Marco Pharma International LLC (161994277)
Establishment
NameAddressID/FEIBusiness Operations
Nestmann Pharma GmbH323426262manufacture(60986-1015)

Revised: 12/2023
Document Id: 0be0cc34-ec75-b6b7-e063-6294a90aadfc
Set id: effc3327-df1b-0c9b-e053-2a95a90a4f29
Version: 2
Effective Time: 20231206
 
Marco Pharma International LLC