Version
v7
Malin and Goetz Acne Treatment — v7
Malin and Goetz Acne Treatment
8 Views
Effective date
October 1, 2025
Original packager
Yes
Sections captured
9
Identifiers
- Document ID
- 401ba64a-bb2a-af37-e063-6394a90afb8a
- Set ID
- 47390813-6bc9-44f4-b72a-d399d2c0de27
- Application numbers
- M006
- Product NDCs
- 53634-010
- Package NDCs
- 53634-010-01, 53634-010-02
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- Malin and Goetz Acne Treatment
- Generic names
- SULFUR
- Manufacturer names
- Malin and Goetz Inc
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- SULFUR
- Routes
- TOPICAL
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- —
- UNII
- 70FD1KFU70
- UPC
- 0891211000213
Structured Label Sections
Active Ingredient (1)
Sequence 1
Active ingredient purpose Sulfur 10% Acne Treatment
Dosage And Administration (1)
Sequence 1
Directions Clean skin thoroughly before applying this product cover the affected area with a thin layer once a day if bothersome dryness or peeling occurs, reduce application to once every other day
Inactive Ingredient (1)
Sequence 1
Inactive Ingredients Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Salicylic Acid, Magnesium Aluminum Silicate
Indications And Usage (1)
Sequence 1
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 acne medication at a time.
Keep Out Of Reach Of Children (1)
Sequence 1
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Package Label Principal Display Panel (1)
Sequence 1
(Malin + Goetz) acne treatment nighttime 10% Sulfur lotion. Overnight Treatment Advanced Technology .5 fl. oz. 14ml acne night treat carton acne treat night jar
Purpose (1)
Sequence 1
Uses treats acne dries up acne pimples helps prevent acne pimples
Spl Product Data Elements (1)
Sequence 1
Malin and Goetz Acne Treatment sulfur ISOPROPYL ALCOHOL WATER ZINC OXIDE CAMPHOR (SYNTHETIC) SALICYLIC ACID MAGNESIUM ALUMINUM SILICATE SULFUR SULFUR
Warnings (1)
Sequence 1
Warnings For External Use only When using this product apply only to areas with acne Do not use on broken skin or large areas of skin
OpenFDA raw payload
{'application_number': ['M006'],
'brand_name': ['Malin and Goetz Acne Treatment'],
'generic_name': ['SULFUR'],
'is_original_packager': [True],
'manufacturer_name': ['Malin and Goetz Inc'],
'package_ndc': ['53634-010-01', '53634-010-02'],
'product_ndc': ['53634-010'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['TOPICAL'],
'spl_id': ['401ba64a-bb2a-af37-e063-6394a90afb8a'],
'spl_set_id': ['47390813-6bc9-44f4-b72a-d399d2c0de27'],
'substance_name': ['SULFUR'],
'unii': ['70FD1KFU70'],
'upc': ['0891211000213']}