The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Shingles Remedy (NDC 68703-213). 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: Croton tiglium 30X, Natrum muriaticum 30X, Plantago major 30X, Rhus tox 30X, Sarsaprilla 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 shingles, including stinging pain, skin lesions, itching and burning associated with herpetic eruptions and infections.
*As per various homeopathic materia medicas. These indications have not been evaluated by the FDA, and product has not been clinically tested.
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 irritation or reaction occurs, discountinue use. Intended to complement, not replace, standard medical care.
Apply to affected areas as needed. Children under 12 years of age: consult a doctor before use.
Paraben free. No petroleum. No animal testing. No artificial colors or fragrances. Cortisone free.
Tamper resistant for your protection. Use only if safety seal is intact.
Purified Water, Phytolacca Americana (Poke) Berry Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol & Caprylyl Glycol & Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-33 & PEG-8 Dimethicone & PEG-14, Larrea Tridentata (Chaparral) Leaf Extract, Hypericum Perforatum (St. John's Wort) Aerial Parts Extract, Symphytum Officinale (Comfrey) Leaf Extract, Phytolacca Americana (Poke) Root Extract, Achillea Millefolium (Yarrow) Flower Extract, Arnica Montana (Arnica) Flower Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Salix Alba (White Willow) Bark Extract, Sodium Hydroxide, Lavandula Angustifolia (Lavender) Buds Extract, Ascorbic Acid, Tocopherols (soy), Edetate Disodium, Natural Plant Extract and Potassium Sorbate. Allergy alert: Soy.
Keep out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Homeopathic Gel
* Please review the disclaimer below.
