Otc - Active Ingredient
Sulfur Precipitated 10%....... Acne Medication
Acne Treatment
FDA Label NDC 82165-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermaline Usa Corp for the product Acne Treatment (NDC 82165-108). 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 - when using, otc - keep out of reach of children, otc - do not use, inactive ingredient, other safety information, otc - questions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - When Using
Uses:
For the treatment of acne. Penetrates the pores and dries and clears pimples and blackheads. Helps to keep new pimples and blackheads from forming.
Adults and children 16 years of age and older. Wash th affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age: consult a doctor.
Otc - Keep Out Of Reach Of Children
Warnings: External Use Only. Keep out of reach of children.
Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.
Otc - Do Not Use
Do not use on wounds or damaged skin, with a bandage, with heating pad, over extensive areas of the body, on children under 16 years of age unless directed by a doctor. If pregnant or breast-feeding ask a health professional before use. In case of accidental ingestion, get medical help or contact a Poison Control center immediately.
Inactive Ingredient
Cetyl/Stearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Polyethyleneglycol, Propyleneglycol, Propylparaben, Sorbitan Oleate, Water
Other Safety Information
Store at controlled room temperature: 15- 30 degrees C (59-86 degree F). Do not expose to excessive heat.
Otc - Questions
Questions? Dermaline USA, 1(800) 371-0171 Weekdays 9am to 4pm. Eastern
Dosage & Administration
Adults and children 16 years of age and older. Wash th affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age: consult a doctor.
Warnings
Warnings: External Use Only. Keep out of reach of children.
Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.
Indications & Usage
Uses:
For the treatment of acne. Penetrates the pores and dries and clears pimples and blackheads. Helps to keep new pimples and blackheads from forming.
Otc - Purpose
Acne Medication
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Label
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