FDA.reportPublic FDA data

Lemaitre Sulfur

Manufacturer
Lemaitre Perfumeria y Jabones SAS
Effective date
2022-11-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:49:38

Label at a glance#

ProductLemaitre Sulfur Acne treatment
Active ingredientSULFUR
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sulfur 9%

OTC - PURPOSE SECTION

Purpose

Acne treatment

INDICATIONS & USAGE SECTION

Uses

  • for the treatment of acne
  • dries and clears acne blemishes, acne pimples, blackheads and whiteheads
  • helps prevent new acne blemishes, acne pimples, blackheads and whiteheads from forming

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on

  • broken skin
  • large areas of the skin

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes
  • apply only to areas with acne
  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time.

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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily. Rinse thoroughly
  • because excessive dryness may occur, start with one application daily, then gradually increase to two or three times daily if needed, or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

INACTIVE INGREDIENT SECTION

Inactive ingredients

sodium palmate, sodium palm kernelate, water, glycerin, sodium chloride, fragrance, etidronic acid, tetrasodium EDTA, BHT, titanium dioxide, FD&C yellow 5. May contain caramel.

SPL UNCLASSIFIED SECTION

Made in Colombia

Distributed by: Lemaitre Perfumeria y Jabones S.A.S

Bosque, Transversal 48 #21-113

Cartagena de Indias, Colombia

Phone: (202) 3706943

www.perfumerialemaitre.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lemaitre

100% VEGETABLE OIL SOAP

Sulfur Soap

acne treatment

Deeply cleanses your skin

Effective action

Net Wt. 3.5 Oz (100g)

Sulfur Soap FinalSulfur Soap Final

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73098-00173098-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARAMELT9D99G2B1RIACT
SODIUM PALMATES0A6004K3ZIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ETIDRONIC ACIDM2F465ROXUIACT
EDETATE SODIUMMP1J8420LUIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
efcaf96c-c309-3627-e053-2a95a90a43fc88c39c90-9f8f-55fa-e053-2995a90a7f5b2024-01-01WarningsExact identifier
spl set id: 88c39c90-9f8f-55fa-e053-2995a90a7f5b

Reported adverse events (FAERS/openFDA)#

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