Otc - Active Ingredient
Sulfur 1X HPUS
Easment Itch Defense Sulfur Cream
FDA Label NDC 87352-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Easment Llc for the product Easment Itch Defense Sulfur Cream (NDC 87352-003). 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 otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - keep out of reach of children, indications & usage, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Mite Symptom Relief
Dosage & Administration
- Temporarily relieves itching and skin discomfort associated with mite exposure.
- Temporarily relieves itching due to bug bites and minor skin irritation.
Warnings
- For external use only.
- Ask a doctor before use if pregnant or nursing.
- When using this product, avoid contact with eyes, mouth, and mucous membranes.
- Stop use and ask a doctor if irritation, rash, or worsening symptoms occur, or if symptoms persist for more than 7 days.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Indications & Usage
- Cleanse and dry the affected area before use.
- Apply a thin layer to theaffected area 1-3 times daily or as needed.
- If excessive dryness occurs,reduce frequency of application or discontinue use.
- Children under 2 years:ask a doctor.
Other Safety Information
- Store at 20-25°C (68-77°F)
- Protect from excessive heat and sunlight
Inactive Ingredient
Aqua, Dipropylene Glycol, Butylene Glycol, Cetearyl Alcohol, Isononyl Isononanoate, Palmitic Acid, Stearic Acid, Glycerin, Dimethicone, Polysorbate 60,PEG-100 Stearate, Glyceryl Stearate, Fomes Officinalis (Mushroom) Extract,1,2-Hexanediol, Hydroxyacetophenone, Polyacrylate Crosspolymer-6, Sorbitan Stearate, Dipotassium Glycyrrhizate, Pentylene Glycol, Lactobacillus/SoymilkFerment Filtrate, Pelargonium Graveolens Flower Oil, Potassium Cetyl Phosphate,Arginine, Butyrospermum Parkii (Shea) Butter, Sophora Flavescens Root Extract,Tribulus Terrestris Fruit Extract, Cornus Officinalis Fruit Extract, Hydroxyphenyl Propamidobenzoic Acid, Pentaerythrityl Tetra-Di-t-Butyl Hydroxyhydrocinnamate,Disodium EDTA, Pandanus Amaryllifolius Leaf Extract, Propanediol, Ascorbyl Palmitate, Ethylhexylglycerin.
Otc - Questions
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