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#
Contacts and useful links#
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
Label
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82165-108-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5df5-111a-e063-dadaa90a10e2 | Dermaline Sulfur |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82165-108-02 | Acne Treatment | 70.9 g in 1 JAR | OINTMENT | 70.9 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Acne Treatment
- Dermaline Sulfur
- GLYCERIN
- GLYCERYL STEARATE SE
- MINERAL OIL
- PARAFFIN
- PROPYLENE GLYCOL 2-PALMITATE
- WATER
- CETYL ALCOHOL
- PEG-6 SORBITAN OLEATE
- POLYETHYLENE GLYCOL 300
- PROPYLPARABEN
- SULFUR
- METHYLPARABEN
- PETROLATUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82165-108 | 82165-108-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL STEARATE SE | FCZ5MH785I | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| PROPYLENE GLYCOL 2-PALMITATE | PD789E82CQ | IACT |
| WATER | 059QF0KO0R | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| PEG-6 SORBITAN OLEATE | 58O7V09UCI | IACT |
| POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SULFUR | 70FD1KFU70 | ACTIB |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e3499b17-5329-9237-e053-2a95a90ac5c0 | e273a835-0ef2-6228-e053-2995a90afb04 | 2022-07-08 | Warnings | e3499b17-5329-9237-e053-2a95a90ac5c0 e273a835-0ef2-6228-e053-2995a90afb04 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
