Label: SULFO LO- sulfur 3% soap bar soap

  • 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 January 11, 2021

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  • ACTIVE INGREDIENT

    Sulfur 3%

  • 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.

  • 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].

  • 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

    P910006

  • INGREDIENTS AND APPEARANCE
    SULFO LO 
    sulfur 3% soap bar soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0118-3599 g in 1 CARTON; Type 0: Not a Combination Product11/01/1965
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/01/1965
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)