Label: SULFO LO- sulfur 3% soap bar soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2023

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  • Active ingredients

    Sulfur 3%

  • Purpose

    Acne Treatment

  • Uses

    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 no 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.

  • Directions

    • Work into a lather and rinse with warm water • Use daily as skin cleanser or as directed by a physician.

  • Other information

    Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].

  • Inactive ingredients

    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

  • PRINCIPAL DISPLAY PANEL

    NDC 0316-0118-35

    sulfo lo®

    Cleansing Bar Soap

    Helps Treat and Manage Acne, Blackheads and Comedones

    DERMATOLOGIST RECOMMENDED

    Net wt. 3.5oz (99 grams)

    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 DrugM00611/01/1965
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
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