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

Acusine by

Drug Labeling and Warnings

Acusine 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 INGREDIENT

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.

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

(Read INDICATIONS & USAGE SECTION)

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60986-1040
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	3 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	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
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	10 [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
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	4 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60986-1040-5	20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/24/2021
2	NDC: 60986-1040-6	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/24/2021

Labeler - Marco Pharma International LLC (161994277)

Registrant - Marco Pharma International LLC (161994277)

Establishment
Name	Address	ID/FEI	Business Operations
Nestmann Pharma GmbH		323426262	manufacture(60986-1040)