SULFO LO- sulfur soap 
Bradford Soap Works, Inc.

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.

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sulfo lo ® Cleansing Bar

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

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

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 finalpart333D01/04/201901/27/2022
Labeler - Bradford Soap Works, Inc. (001201045)
Establishment
NameAddressID/FEIBusiness Operations
Bradford Soap Works, Inc.001201045manufacture(11118-0007)

Revised: 3/2023
Document Id: f67bf429-5e85-349f-e053-2a95a90a942a
Set id: 5ca81d16-2f90-49be-a150-b797c97f740d
Version: 5
Effective Time: 20230309
 
Bradford Soap Works, Inc.