The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Well-ex (NDC 68703-318). 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: Equal volumes of each ingredient: Arsenicum alb 6C, Graphites 6C, Hepar sulph calc 6C, Radium brom 30C, Viola tric 6C.
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Uses*: Soothes transient itching and weeping of skin during an eczema 'flare up'.
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of oversdose, get medical help or contact a Poison Control Center right away.
Directions: Chew or dissolve tablets in the mouth. Alternatively, crush and sprinkle directly on the tongue or mix in warm water or soft food. Use 3 times daily, 30 minutes before food, until symptoms subside. Adults & children 13+: 2 tablets. Childeren 2-12: 1 tablet.
Contains no artificial flavors or colorants. No gluten added.
Tamper resistant for your protection. Use only if safety seal is intact.
Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose.
Keep this and all medication out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Soothes symptoms of transient skin flare-ups in children with eczema or atopic dermatitis.
* Please review the disclaimer below.
