Naturasil Tinea Versicolor Relief Lotion
FDA Label NDC 10893-241
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nature's Innovation, Inc. for the product Naturasil Tinea Versicolor Relief (NDC 10893-241). 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 drug facts, active ingredients, purpose, uses:, warnings:, otc - keep out of reach of children, directions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Sulfur 6X HPUS
The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.
Purpose
Tinea Versicolor Symptom Relief
Uses:
Symptomatic treatment of Tinea Versicolor.
Warnings:
SHAKE WELL! For external use only.
Ask a doctor before use if pregnant or nursing. Avoid using near eyes, mouth or mucous membranes.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Do not use if tamper evident seal is broken. In case of ingestion, call Poison Control Center hotline immediately at 1-800-222-1222.
Directions:
Shake well. Cleanse skin thoroughly with Tinea Versicolor Soap before applying lotion. Apply lotion 2-3 times per day to affected area until tinea versicolor has cleared. This lotion is part of a two-part system requiring you to use both the soap and lotion together. Re-exposure to UV ray (the sun) is essential in bringing back the melanin pigment of your skin. Some individuals may be sensitive to essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.
Inactive Ingredients:
Aqua, Carbomer, Cetearyl Alcohol, Cymbopogon Citratus Leaf Oil, Eucalyptus Leaf Oil, Glyceryl Stearate, Helianthus Annus (Sunflower) Seed Oil, Jojoba Seed Oil, Lavender Oil, Melaleuca Alternifolia Leaf Oil, Patchouli Leaf Oil, Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Sodium Hydroxide.
Packaging
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