The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Eczema Remedy (NDC 68703-214). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding hpus active ingredients, uses*, warnings, directions, other safety information, inactive ingredients, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
HPUS** Active Ingredients: Carbolicum acidum 30X, Fagopyrum esculentum 30X, Hydrastis canadensis 30X, Hydrocotyle asiatica 30X, Juglans regia 30X, Vinca minor 30X.
**"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Indications*: May temporarily relieve signs and symptoms associated with eczema such as rashes, hives, eruptions, and skin inflammation as well as temporarily soothe skin that is red, burning, itchy, dry, scaly, chapped or cracked.
*As per various homeopathic materia medicas. These indications have not been evaluated by the FDA, and product has not been clinically tested.
Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. For external use only. Avoid using near eyes or mouth. If swallowed, get medical help or contact a Poison Control Center immediately. Some individuals may be sensitive to ingredients, if irritiation or reaction occurs, discontinue use. Intended to complement, not replace, standard medical care.
Apply to affected areas at least 3 times per day. Children under 12 years of age: consult a doctor before use.
Paraben free. No petroleum. No animal testing. No artificial colors or fragrances.
Tamper resistant for your protection. Use only if safety seal is intact.
Purified Water, Phytolacca Americana (Poke) Berry Extract, Olea Europaea (Olive) Oil, Persea Gratissima (Avocado) Oil, Macadamia Integrifolia Seed Oil, Phenoxyethanol & Caprylyl Glycol & Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, PEG-33 & PEG-8 Dimethicone & PEG-14, Aleurites Moluccana (Kukui) Seed Oil, Polysorbate 20, Larrea Tridentata (Chaparral) Leaf Extract, Phytolacca Americana (Poke) Root Extract, Sodium Hydroxide, Arnica Montana (Arnica) Flower Extract, Hypericum Perforatum (St. John's Wort) Aerial Parts Extract, Salix Alba (White Willow) Bark Extract, Ascorbic Acid, Azadirachta Indica (Neem) Leaf Extract, Calendula Officinalis (Calendula) Flower Extract, Tocopherols (soy), Edetate Disodium, Natural Plant Extract and Potassium Sorbate. Allergy alert: Macadamia and Kukui Nut Oils and Soy.
Keep out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Homeopathic Lotion
* Please review the disclaimer below.
