SulfaCLEAR Cleansing bar soap (3%) Sulfur

SulfaCLEAR by

Drug Labeling and Warnings

SulfaCLEAR by is a Otc medication manufactured, distributed, or labeled by Burke Therapeutics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SULFACLEAR- sulfaclear cleansing bar soap soap 
Burke Therapeutics, LLC

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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SulfaCLEAR

Cleansing bar soap

(3%) Sulfur

Description

sulfaCLEAR Cleansing bar soap

3% Sulfur

Net Wt 3.5 oz (99g)

Acne Treatment Soap

Warnings Section

For External Use Only

Do not use on:

• broken skin
• large areas of the skin

When using this product:

• apply only to areas with acne
• do not get into eyes
• if excessive skin irritation develops or increases, disconstinue use and consult a physician
• using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used otherwise directed by 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. If swallowed get medical help or contact a Poison Control Center

Purpose

Treatment of acne and blackheads

Dosage and Administration

Gently wash affected areas with sulfaClean Cleansing Bar Soap.

Allow lather to remain on the skin for three to five minutes. Rinse thoroughly with warm water and gently pat dry with clean towel. May be used from one to three times a day. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

Indications and Usage

Use for the treatment of Acne

Active Ingredients

Ingredients:

3% sulfur

Inactive Ingredients

Inactive ingredients:

Sodium Palmate, Sodium Palm Kernelate, Water, Sulfur, Eucalyptus Globulus Leaf Oil, Sodium Chloride, Glycerin, Butyrospermum Parkii (Shea Butter), Titanium Dioxide, Tetrasodium EDTA, Tetrasodium Etidronate, Yellow 10 (CI 47005), Red 4, Iron Oxides (CI 77499)

Storage and Handling

Store at controlled room temperature 50º-86ºF (15º-30ºC)

Package Label Principal Display Panel

Distributed by:

Burke THERAPEUTICS

Hot Springs, AR 71913

501-542-4052

www.burketherapeutics.com

SULFACLEAR 
sulfaclear cleansing bar soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69101-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	0.33 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PALMATE (UNII: S0A6004K3Z)
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
SHEA BUTTER (UNII: K49155WL9Y)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69101-700-01	1 in 1 BOX; Type 0: Not a Combination Product	01/26/2017	05/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/26/2017	05/31/2019

Labeler - Burke Therapeutics, LLC (079259903)

Registrant - Burke Therapeutics, LLC (079259903)

Establishment
Name	Address	ID/FEI	Business Operations
Burke Therapeutics, LLC		079259903	manufacture(69101-700)

Revised: 11/2019

Document Id: 9767c2fa-2e78-255a-e053-2a95a90ac88c

34390-5

Set id: 476aeb71-b97a-59fb-e054-00144ff8d46c

Version: 5

Effective Time: 20191115

 

Burke Therapeutics, LLC