FDA Label for Sulfo Lo
View Indications, Usage & Precautions
Sulfo Lo Product Label
The following document was submitted to the FDA by the labeler of this product Crown Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Sulfur 3%
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
* Please review the disclaimer below.