SulfaCLEAR

Manufacturer
Burke Therapeutics, LLC
Effective date
2019-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:02:44

Label at a glance#

ProductSulfaCLEAR
Active ingredientSULFUR
Label structure8 sections

Indications and uses

Use for the treatment of Acne

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.

Storage and handling

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

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children. If swallowed get medical help or contact a Poison Control Center

Purpose

OTC - PURPOSE SECTION

Treatment of acne and blackheads

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

Use for the treatment of Acne

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ingredients:

3% sulfur

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:

Burke THERAPEUTICS

Hot Springs, AR 71913

501-542-4052

www.burketherapeutics.com

Carton LabelCarton Label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69101-70069101-700-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9767c2fa-2e78-255a-e053-2a95a90ac88c476aeb71-b97a-59fb-e054-00144ff8d46c2019-11-15WarningsExact identifier
spl set id: 476aeb71-b97a-59fb-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.