Label: ACNE TREATMENT WITH SULFUR- sulfur ointment
- NDC Code(s): 24286-1573-1, 24286-1573-2
- Packager: DLC Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 21, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
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Directions
- cleanse the skin thoroughly before applying
- cover the entire affected area with a thin layer
- leave on for 10 minutes
- thoroughly remove with water
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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
- Inactive ingredient
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 74 g Tube Label
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INGREDIENTS AND APPEARANCE
ACNE TREATMENT WITH SULFUR
sulfur ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1573 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24286-1573-1 74 g in 1 TUBE; Type 0: Not a Combination Product 08/16/2019 2 NDC:24286-1573-2 6 g in 1 JAR; Type 0: Not a Combination Product 09/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/16/2019 Labeler - DLC Laboratories, Inc. (093351930)