FDA.reportPublic FDA data

SULFUR ACNE TREATMENT

Manufacturer
Xtreme Tools International, Inc
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:43:48

Label at a glance#

ProductSULFUR ACNE TREATMENT
Active ingredientSULFUR
Label structure11 sections

Dosage and administration

Wet face. Work soap into a lather with hands and gently massage onto skin. Rinse.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur (10%)

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warning

WARNINGS SECTION

For External use only

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 medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Do not use on

OTC - DO NOT USE SECTION

■ broken skin ■ Large areas of the skin.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet face. Work soap into a lather with hands and gently massage onto skin. Rinse.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sodium Palmate, Sodium Palm Kernelate, Sodium Cocoate, Water (Aqua), Glycerin, Cocos nucifera (Coconut) Oil, Rosa Moschata Seed (Rosehip) Oil, Psidium Guajava Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Allantoin, Tocopheryl Acetate, Tetrasodium Etidronate, Sodium Chloride, Fragrance.

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-305-622-7474 Mon-Fri 9 am-5 pm

Pacakge Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 74553-13-01

Facial SoapFacial Soap

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74553-01374553-013-01

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
SULFUR70FD1KFU70ACTIB
SODIUM PALMATES0A6004K3ZIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
SODIUM COCOATER1TQH25F4IIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
COCONUT OILQ9L0O73W7LIACT
ROSA MOSCHATA SEED OILT031ZE559TIACT
PSIDIUM GUAJAVA LEAFPM0F263X0YIACT
PAPAYAKU94FIY6JBIACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETIDRONATE TETRASODIUMCZZ9T1T1X4IACT
SODIUM CHLORIDE451W47IQ8XIACT

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
4a9270cc-1e00-45eb-886b-23055e330eb82ddcb2ec-c93c-47cc-88f5-3e83a0cf36592025-03-21WarningsExact identifier
spl set id: 2ddcb2ec-c93c-47cc-88f5-3e83a0cf3659

Reported adverse events (FAERS/openFDA)#

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