Acne Treatment

Manufacturer
Dermaline USA corp
Effective date
2022-07-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:06

Label at a glance#

ProductAcne Treatment
Active ingredientSULFUR
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sulfur Precipitated 10%....... Acne Medication

OTC - WHEN USING SECTION

Uses:

For the treatment of acne. Penetrates the pores and dries and clears pimples and blackheads. Helps to keep new pimples and blackheads from forming.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings: External Use Only. Keep out of reach of children.

Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.

OTC - DO NOT USE SECTION

Do not use on wounds or damaged skin, with a bandage, with heating pad, over extensive areas of the body, on children under 16 years of age unless directed by a doctor. If pregnant or breast-feeding ask a health professional before use. In case of accidental ingestion, get medical help or contact a Poison Control center immediately.

OTC - WHEN USING SECTION

Adults and children 16 years of age and older. Wash th affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

Cetyl/Stearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Polyethyleneglycol, Propyleneglycol, Propylparaben, Sorbitan Oleate, Water

OTHER SAFETY INFORMATION

Store at controlled room temperature: 15- 30 degrees C (59-86 degree F). Do not expose to excessive heat.

OTC - QUESTIONS SECTION

Questions? Dermaline USA, 1(800) 371-0171 Weekdays 9am to 4pm. Eastern

DOSAGE & ADMINISTRATION SECTION

Adults and children 16 years of age and older. Wash th affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age: consult a doctor.

WARNINGS SECTION

Warnings: External Use Only. Keep out of reach of children.

Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.

INDICATIONS & USAGE SECTION

Uses:

For the treatment of acne. Penetrates the pores and dries and clears pimples and blackheads. Helps to keep new pimples and blackheads from forming.

OTC - PURPOSE SECTION

Acne Medication

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313148sulfur 10 % Topical OintmentPSN2
313148sulfur 0.1 MG/MG Topical OintmentSCD2
313148sulfur 10 % Topical OintmentSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82165-108-022024-01-30C16284748780-11030e365-5df5-111a-e063-dadaa90a10e2Dermaline Sulfur

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82165-108-02Acne Treatment70.9 g in 1 JAROINTMENT70.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82165-108ACNE TREATMENT (DERMALINE SULFUR) OINTMENT [DERMALINE USA CORP]2Legacy NDC, 1 package rows20220709_e273a835-0ef2-6228-e053-2995a90afb04.zip

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
82165-10882165-108-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e3499b17-5329-9237-e053-2a95a90ac5c0e273a835-0ef2-6228-e053-2995a90afb042022-07-08WarningsExact identifier
spl id: e3499b17-5329-9237-e053-2a95a90ac5c0
spl set id: e273a835-0ef2-6228-e053-2995a90afb04

Reported adverse events (FAERS/openFDA)#

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