Label: SULFO LO- sulfur 3% soap bar soap
- NDC Code(s): 0316-0118-35
- Packager: Crown Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 13, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SULFO LO
sulfur 3% soap bar soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-0118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 30 mg in 1 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW) SODIUM COCOATE (UNII: R1TQH25F4I) SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PENTASODIUM PENTETATE (UNII: 961TOZ5L7T) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) BROWN IRON OXIDE (UNII: 1N032N7MFO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SHEA BUTTER (UNII: K49155WL9Y) BASIC YELLOW 5 (UNII: 07BP340B4T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-0118-35 99 g in 1 CARTON; Type 0: Not a Combination Product 11/01/1965 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/01/1965 Labeler - Crown Laboratories (079035945) Registrant - Crown Laboratories (079035945)