ACUNOL- nickel sulfate, potassium bromide, sodium bromide, zinc sulfate anhydrous, and sulfur tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NICKEL SULFATE (UNII: 4FLT4T3WUN) (NICKEL CATION - UNII:OIS2CXW7AM), POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06), SODIUM BROMIDE (UNII: LC1V549NOM) (BROMIDE ION - UNII:952902IX06), ZINC SULFATE ANHYDROUS (UNII: 0J6Z13X3WO) (ZINC CATION - UNII:13S1S8SF37), SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)

Available from:

PLYMOUTH HEALTHCARE PRODUCTS LLC

INN (International Name):

Nickel Sulfate

Composition:

Nickel Sulfate 1 [hp_X]

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acunol™ is indicated for the treatment of mild to moderate acne vulgaris, acne rosacea, peri-oral dermatitis, and folliculitis. It has been found to work well with a variety of combination therapies. Although there are no known contraindications, patients who are allergic to any Acunol™ ingredient should consult a physician prior to taking the medication. (Refer to Section on Hypersensitivity)

Product summary:

Scored tablets, off white in color with green speckles, with imprinted on one side and a score on the other side , in child-resistant and tamper-resistant bottles of 90. NDC 61480-137-05

Authorization status:

unapproved homeopathic

Summary of Product characteristics

ACUNOL- NICKEL SULFATE, POTASSIUM BROMIDE, SODIUM BROMIDE, ZINC
SULFATE
ANHYDROUS, AND SULFUR TABLET
PLYMOUTH HEALTHCARE PRODUCTS 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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ACUNOL™
CAUTION
Federal law prohibits dispensing without a prescription.
DESCRIPTION
Acunol™ is a biochemical homeopathic medication indicated for the
TREATMENT OF
ACNE.
The active ingredients in each Acunol™ tablet consist of the
following:
Potassium Bromide (Kali Bromatum) 1X, Sodium Bromide (Natrum Bromatum)
1X, Zinc
Sulphate (Zincum Sulphuricum) 1X, Sulphur 1X, and Nickel Sulphate
(Niccolum
Sulphuricum) 1X. These drug ingredients are listed in the Homoeopathic
Pharmacopoeia
of the United States (HPUS).
Inactive ingredients: Lactose, Magnesium Stearate, and Copper (II)
Oxide.
PHARMACOLOGICAL CLASS: Homeopathic drug.
DOSAGE FORM: Oral 600 mg scored tablet. May be swallowed whole, chewed
or
dissolved in the mouth and swallowed.
CLINICAL PHARMACOLOGY
The active ingredients in Acunol™ are simple biochemical compounds.
The exact
mechanism of action is unknown; however, it is known that bromide
enhances
phagocytic and bactericidal activity of neutrophils.
POTASSIUM BROMIDE & SODIUM BROMIDE dissolve and dissociate in the
digestive
tract into their ionic constituents. Each tablet contains
approximately 30 mg of bromide
(calculated). Ionic bromide is rapidly and completely absorbed from
the intestine and
distributed almost exclusively in the extracellular fluids.
Bromide is eliminated by the
kidneys and the elimination half-life is 11-12 days.
ZINC SULPHATE dissolves and dissociates in the digestive tract into
its ionic
constituents. Each tablet contains approximately 5 mg of zinc
(calculated). Zinc is an
essential trace mineral necessary for protein synthesis, enzyme
stimulation, and alkaline
balance.
It is primarily absorbed from the duodenum and excreted via feces,
ur