Potassium Bromide, Nickel Sulfate, and Sulfur

INDICATIONS ECZEMOL ® is indicated for the treatment of moderate to severe eczema and atopic dermatitis. 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 ECZEMOL ® ingredient should consult a physician prior to taking the medication. (Refer to Section on Hypersensitivity)

Do not use if imprinted seal under bottle cap is missing or broken. Do not use if pregnant or nursing. If allergic to nickel or metal objects such as jewelry or if there is a history of blistering hand eczema, see PRECAUTIONS for hypersensitivity information. Lactose intolerant patients may have gastrointestinal difficulty. This has very rarely been reported at the doses used.

Carefully adjust dosage to weight when treating young children. Use cautiously in setting of kidney disease. (see Dosage and Administration ) If skin rash appears or if nervous symptoms persist, recur frequently, or are unusual, discontinue use. Hypersensitivity Caution should be used when administering to patients with a history of contact sensitivity to nickel (common metal exposure) or if there is a history of vesicular hand eczema (dyshidrosis, pomphylox). Nickel allergy may be confirmed by a positive nickel patch test. Most patients with hand eczema, positive nickel allergy history, or a positive nickel patch test do not have any untoward reaction to administration of ECZEMOL ® . If there is a history of nickel sensitivity or dyshidrotic hand eczema, begin with a very low dose and slowly increase to a recommended starting dose over a period of 5 weeks as tolerated, thus allowing progressive GI absorption * . *Nickel desensitization schedule: Week Amount of Time to Take Medication Prior to Breakfast Week 1 With Breakfast Week 2 15 min Prior Week 3 30 min Prior Week 4 45 min Prior Week 5 and thereon 1 hour Prior If new pruritic rashes occur or persist, discontinue ECZEMOL ® and treat appropriately. Do not use if there is a history of extra-cutaneous hypersensitivity to nickel or any ingredient in ECZEMOL ® . Information for patients Patients using ECZEMOL ® should receive the following information and instructions: This medication is to be used as directed by a physician. It is important to take orally at the beginning of the day on an empty stomach (or any convenient time after having taken nothing but water for at least 7 hours) and to eat or drink nothing but water for at least one hour afterwards to avoid interference with absorption. Drug interactions There are no known drug interactions. Carcinogenesis, mutagenesis, impairment of fertility No studies have been done on the carcinogenesis, mutagenesis, or impairment of fertility of ECZEMOL ® . No carcinogenesis or mutagenesis has been reported in multiple animal studies for oral administration of soluble nickel and bromide salts (active ingredients) even at very high doses. 10-14 Effects of soluble potassium bromide KBr is not listed as a carcinogen by the NTP, IARC, and OSHA. 16 Effects of sulphur Sulphur is not listed as a carcinogen by the ACGIH, IARC, NIOSH, NTP, or OSHA. 25 Effects of soluble nickel sulphate Studies on experimental animals have never indicated that nickel, at any dose, is a carcinogen when introduced to the body orally. Furthermore, Nickel sulphate and other highly water soluble nickel salts, have never been known to induce carcinogenesis via any route of introduction including: oral, inhalation, cutaneous, IM, or IP. 10-12,15 No adverse effects were noted on fertility or reproduction in a 3-generational study of albino Wistar rats fed up to 1000 ppm Ni per day, which is equivalent to 50 mg/kg body weight per day Ni. 15 Pregnancy Pregnancy category C Animal reproduction studies have not been conducted with ECZEMOL ® . ECZEMOL ® should not be given to a pregnant woman. Nursing mothers It is not known whether this drug is excreted in human milk. However, since many drugs are excreted in human milk, caution should be exercised when ECZEMOL ® is administered to a nursing woman. Pediatric use Carefully adjust dosage to weight when treating young children.

ECZEMOL ® contains low doses of active ingredients. Therefore there are minimal known side effects. (see PRECAUTIONS for hypersensitivity information)

There are no known drug interactions.

Pregnancy category C Animal reproduction studies have not been conducted with ECZEMOL ® . ECZEMOL ® should not be given to a pregnant woman.

It is not known whether this drug is excreted in human milk. However, since many drugs are excreted in human milk, caution should be exercised when ECZEMOL ® is administered to a nursing woman.

Carefully adjust dosage to weight when treating young children.