FDA.reportPublic FDA data

Sulfaderm

Manufacturer
Pharmadel LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:45:22

Label at a glance#

ProductSulfaderm
Active ingredientSULFUR
Label structure9 sections

Indications and uses

For the treatment of acne. Clears up acne: blemishes pimples blackheads whiteheads

Dosage and administration

cleanse the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily 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 if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient

Purpose
Sulfur 10% ........................Acne treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne. Clears up acne:

  • blemishes
  • pimples
  • blackheads
  • whiteheads

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not use on

OTC - DO NOT USE SECTION

  • broken skin
  • large areas of the skin

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness are 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.
  • apply only to areas with acne

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • cleanse the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • 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
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

OTHER SAFETY INFORMATION

  • store between (59-86°F) 15-30°C
  • don’t use if clear seal over cap is broken, torn, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyostearyl alcohol, glycerin, glyceryl monostearate, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, polyethylene

glycol, sorbitan monooleate, water

Distributed by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP SulfurPDP Sulfur

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-37955758-379-02

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
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
SULFUR70FD1KFU70ACTIB
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
GLYCERINPDC6A3C0OXIACT

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
45269c52-e9cd-e3c4-e063-6394a90a667dfdcaaa56-a27d-5bd9-e053-6294a90a11602025-12-04WarningsExact identifier
spl id: 45269c52-e9cd-e3c4-e063-6394a90a667d
spl set id: fdcaaa56-a27d-5bd9-e053-6294a90a1160

Reported adverse events (FAERS/openFDA)#

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