SULFO LO- sulfur 3% soap bar soap

Sulfo lo by

Drug Labeling and Warnings

Sulfo lo by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SULFO LO 
sulfur 3% soap bar soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0118
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
.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)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHEA BUTTER (UNII: K49155WL9Y)
BASIC YELLOW 5 (UNII: 07BP340B4T)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-0118-35	99 g in 1 CARTON; Type 0: Not a Combination Product	11/01/1965

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/01/1965

Labeler - Crown Laboratories (079035945)

Registrant - Crown Laboratories (079035945)