Otc - Active Ingredient
Sulfur 3%
Sulfo Lo Soap
FDA Label NDC 0316-0118
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Crown Laboratories for the product Sulfo Lo (NDC 0316-0118). 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, indications & usage, warnings, otc - keep out of reach of children, inactive ingredient, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne Treatment
Indications & Usage
Deep cleansing antibacterial soap for management of acne, blackheads and comedones.
Warnings
• FOR EXTERNAL USE ONLY • Avoid contact with eyes, wash with water if exposed • Do not use on • broken skin • large areas of skin • When using this product • apply only to areas with acne • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. • If irritation occurs, only use one topical acne medication at a time • If undue irritation persists consult a physician • Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center.
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children.
Inactive Ingredient
Sodium Tallowate, Sodium Cocoate/Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Sodium Chloride, Butyrospermum parkii (Shea) Butter, Yellow 5 (CI19140), Titanium Dioxide (CI77891), Pentasodium Pentetate, Tetrasodium Etidronate, Iron Oxides (CI77492), Tocopheryl Acetate
Dosage & Administration
• Work into a lather and rinse with warm water • Use daily as skin cleanser or as directed by a physician.
Storage And Handling
Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].
Package Label.Principal Display Panel
NDC 0316-0118-35
sulfo lo®
Cleansing Bar Soap
Helps Treat and Manage Acne, Blackheads and Comedones
DERMATOLOGIST RECOMMENDED
Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604
www.crownlaboratories.com | 800.334.4286 | Made in the USA
P9100.06
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