Sulfo lo by Bradford Soap Works, Inc. SULFO LO- sulfur soap

Sulfo lo by

Drug Labeling and Warnings

Sulfo lo by is a Otc medication manufactured, distributed, or labeled by Bradford Soap Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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)

INGREDIENTS AND APPEARANCE

SULFO LO 
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11118-0007
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11118-0007-1	99 g in 1 CARTON; Type 0: Not a Combination Product	01/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/04/2019

Labeler - Bradford Soap Works, Inc. (001201045)

Establishment
Name	Address	ID/FEI	Business Operations
Bradford Soap Works, Inc.		001201045	manufacture(11118-0007) , label(11118-0007)