SULFO LO- sulfur 3% soap bar soap

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)
Available from:
Crown Laboratories
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Treatment Deep cleansing antibacterial soap for management of acne, blackheads and comedones.
Authorization status:
OTC monograph final
Authorization number:
0316-0118-35

SULFO LO- sulfur 3% soap bar soap

Crown Laboratories

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 Soap

Sulfur 3%

Acne Treatment

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

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.

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

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

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

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

SULFO LO

sulfur 3% soap bar soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 316 -0 118

Route of Administration

TOPICAL

Crown Laboratories

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

30 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

.ALPHA.-TO CO PHERO L ACETATE, D- (UNII: A7E6 112E4N)

SO DIUM TALLO WATE, BEEF (UNII: 0 7RIK6 QMEW)

SO DIUM CO CO ATE (UNII: R1TQH25F4I)

SO DIUM PALM KERNELATE (UNII: 6 H9 1L1NXTW)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

ETIDRO NATE TETRASO DIUM (UNII: CZZ9 T1T1X4)

BRO WN IRO N O XIDE (UNII: 1N0 32N7MFO)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SHEA BUTTER (UNII: K49 155WL9 Y)

BASIC YELLO W 5 (UNII: 0 7BP340 B4T)

PENTASO DIUM PENTETATE (UNII: 9 6 1TOZ5L7T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 316 -0 118 -35

9 9 g in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

11/0 1/19 6 5

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333D

11/0 1/19 6 5

Labeler -

Crown Laboratories (079035945)

Registrant -

Crown Laboratories (079035945)

Revised: 5/2019

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