AMMONIUM: 296 Adverse Event Reports & Safety Profile

DESCRIPTION *Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a lotion pH of 4.5 to 5.5.

Ammonium Lactate

Lotion also contains cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, polyoxyethylene 100 stearate, polyoxyl stearate type II, propylene glycol, propylparaben, purified water, and for pH adjustment: lactic acid. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: Chemical Structure

INDICATIONS: Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. † †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

DIRECTIONS At first sign of symptoms: Adults and children 12 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Standard dosage: Adults and children 12 years and older: take 1-2 tablets 4 to 6 hours. Do not exceed 12 tablets in 24 hours. For children under 12, consult your health professional. Allow tablets to dissolve completely in the mouth, do not swallow.

CONTRAINDICATIONS Ammonium Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

ADVERSE REACTIONS In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10 to 15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

WARNINGS: Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN . In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away. Do not use if TAMPER EVIDENT seal is broken or missing. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache consult a doctor.

PRECAUTIONS General For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded (for example, after shaving the legs). Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied. Information for Patients Patients using Ammonium Lactate Cream, 12% should receive the following information and instructions: This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with the eyes, lips, or mucous membranes. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs). If the skin condition worsens with treatment, the medication should be promptly discontinued. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 Carcinogenesis, Mutagenesis, Impairment of Fertility The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate cream enhanced the rate of ultraviolet light-induced skin tumor formation. The mutagenic potential of ammonium lactate cream was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative. In dermal Segment I and III studies with ammonium lactate cream there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m 2 /day), approximately 0.4 times the human topical dose.

Pregnancy

Teratogenic effects Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m 2 /day in the rat and 7200 mg/m 2 /day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ammonium Lactate Cream, 12% should be used during pregnancy only if clearly needed.

Nursing Mothers

Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ammonium Lactate Cream, 12% is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Ammonium Lactate Cream, 12% have been established in pediatric patients as young as 2 years old.

Geriatric Use

Clinical studies of Ammonium Lactate Cream, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

ACTIVE INGREDIENTS/PURPOSE CHAMOMILLA 3X RELIEVES INFLAMMATION GLANDULA SUPRARENALIS SUIS 6X 12X 30X SUPPORTS METABOLISM MUCOSA NASALIS SUIS 200X RELIEVES ALLERGY SYMPTOMS SCILLA MARITIMA 12X 30X 200X RELIEVES DRY COUGH SABADILLA 12X 30X 200X RELIEVES HAY FEVER ALLIUM CEPA 12X 30X 200X RELIEVES RESPIRATORY CONGESTION AMMONIUM CARBONICUM 12X 30X 200X RELIEVES RESPIRATORY CONGESTION APIS MELLIFICA 200X HELPS REDUCE SWELLING ARGENTUM NITRICUM 30X RELIEVES INFLAMMATION ARSENICUM ALBUM 12X 30X 200X RELIEVES INFLAMMATION CUPRUM ACETICUM 12X 30X 200X RELIEVES HAY FEVER, PERSISTENT COUGH GALPHIMIA GLAUCA 6X 12X 200X RELIEVES HAY FEVER LUFFA OPERCULATA 6X 12X 30X RELIEVES HAY FEVER HISTAMINUM HYDROCHLORICUM 200X RELIEVES ALLERGY SYMPTOMS NATRUM MURIATICUM 12X 30X 200X RELIEVES ALLERGY SYMPTOMS ADRENALINUM 6X IMMUNE SUPPORT

INGREDIENTS Avena sativa 1x, Valeriana officinalis 1x, Humulus lupulus 2x, Coffea cruda 4x, Ignatia amara 6x, Zincum valerianicum 9c, Ammonium bromatum 3x, Chamomilla vulgaris 4x, Eschscholtzia californica 2x, Passiflora incarnata 2x, 32% alcohol in purified water.