Label: SULFO LO- sulfur soap

  • NDC Code(s): 11118-0007-1
  • Packager: Bradford Soap Works, Inc.
  • 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 November 9, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Sulfur 3%

  • Purpose

    Acne Treatment

  • Indications & Useage 

    Deep cleansing antibacterial soap for management of acne, blackheads and comedones.

  • Warnings 

    • For external use only • Avoid contact with eyes, was with water if exposed • Do not use on • broken skin • large areas of skin • 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 Etidonate, 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 & Handling

    Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature

  • PRINCIPAL DISPLAY PANEL

    Drug Facts

    Active Ingredients                                                                                                              Purpose

    Sulfur 3% ……………………………………………………………………………………………… Acne Treatment

    Uses Deep cleansing antibacterial soap for management of acne, blackheads and comedones.

    Warnings

    • § For external use only • Avoid contact with eyes, was with water if exposed • Do not use on • broken skin • large areas of skin • 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 Etidonate, Iron Oxides (CI77492), Tocopheryl Acetate

    Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

    www.crownlaboratories.com | 800.334.4286 | Made in the USA

    P9100.06

     sulfo lo®

    Cleansing Bar Soap

    Helps Treat and Manage Acne, Blackheads and Comedones

    NDC 0316-0118-35

    sulfo lo®

    Cleansing Bar Soap

    Helps Treat and Manage Acne, Blackheads and Comedones

    DERMATOLOGIST RECOMMENDED

    Net wt. 3.5 oz (99 grams)

    NDC 0316-0118-35

    sulfo lo®

    Cleansing Bar Soap

    Net wt. 3.5 oz (99 grams)

     sulfo lo®

    Cleansing Bar Soap

    Helps Treat and Manage Acne, Blackheads and Comedones

    sulfo lo

  • INGREDIENTS AND APPEARANCE
    SULFO LO 
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11118-0007
    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
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11118-0007-199 g in 1 CARTON; Type 0: Not a Combination Product01/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/04/2019
    Labeler - Bradford Soap Works, Inc. (001201045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bradford Soap Works, Inc.001201045manufacture(11118-0007) , label(11118-0007)