FDA.reportPublic FDA data

Sulfo lo

Manufacturer
Crown Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:33:39

Label at a glance#

ProductSulfo lo
Active ingredientSULFUR
Label structure8 sections

Indications and uses

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

Dosage and 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].

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sulfur 3%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

• For external use only • Avoid contact with eyes, wash with water if exposed

•Do no use on

OTC - DO NOT USE SECTION

• broken skin • large areas of skin

• When using this product

OTC - WHEN USING SECTION

• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• If swallowed, get medical help or contact a Poison Control Center.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0316-0118-35

sulfo lo®

Cleansing Bar Soap

Helps Treat and Manage Acne, Blackheads and Comedones

DERMATOLOGIST RECOMMENDED

Net wt. 3.5oz (99 grams)

Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604
www.crownlaboratories.com | 800.334.4286 | Made in the USA

P9100.06

P910006P910006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
212397Sulfo-Lo 3 % Medicated Bar SoapPSN6
248410sulfur 3 % Medicated Bar SoapPSN6
212397sulfur 0.03 MG/MG Medicated Bar Soap [Sulfo-Lo]SBD6
248410sulfur 0.03 MG/MG Medicated Bar SoapSCD6
212397Sulfo-Lo 3 % Medicated Bar SoapSY6
248410sulfur 3 % Medicated Bar SoapSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130303160118357GTIN-13: 0303160118357
EAN-13: 0303160118357
GTIN-12: 303160118357
UPC-A: 303160118357
GTIN storage (14 digits): 00303160118357		P910006 _SulfoLo.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0118-352023-02-13C16284748780-1f386c649-ed2d-0266-e053-dadaa90a7c1aSulfo-Lo Cleansing Bar Soap
0316-0118-352023-02-13C16284748780-1f386c649-ed2d-0266-e053-dadaa90a7c1aSulfo-Lo Cleansing Bar Soap
0316-0118-352023-01-30C16284748780-1f386c649-ed2d-0266-e053-dadaa90a7c1aSulfo-Lo Cleansing Bar Soap
0316-0118-352023-01-30C16284748780-1f386c649-ed2d-0266-e053-dadaa90a7c1aSulfo-Lo Cleansing Bar Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0118-35Sulfo lo99 g in 1 CARTONSOAP996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0118-35EA - Each0316-0118798cb2da-4fb1-4bf1-aad3-e5053b22282112021-11-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-01180316-0118-35

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
SULFUR70FD1KFU70ACTIB
SODIUM TALLOWATE, BEEF07RIK6QMEWIACT
SODIUM COCOATER1TQH25F4IIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
PENTASODIUM PENTETATE961TOZ5L7TIACT
ETIDRONATE TETRASODIUMCZZ9T1T1X4IACT
BROWN IRON OXIDE1N032N7MFOIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SHEA BUTTERK49155WL9YIACT
BASIC YELLOW 507BP340B4TIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-11-17monthly-update2026-06-03 17:40:15

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfo loSULFUR 3% SOAP BARCrown Laboratories89577417-76a0-cb04-e053-2995a90a57332026-01-12WarningsExact identifier
ndc (package): 0316-0118-35
ndc (product): 0316-0118
ndc11 (package): 00316011835
spl id: 4833e6b4-3673-08d5-e063-6394a90aa791
spl set id: 89577417-76a0-cb04-e053-2995a90a5733

Reported adverse events (FAERS/openFDA)#

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