Label: ACNE TREATMENT- dermaline sulfur ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 82165-108-02 - Packager: Dermaline USA corp
- 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 July 8, 2022
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- ACTIVE INGREDIENT
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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DO NOT USE
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.
- WHEN USING
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- QUESTIONS
- DOSAGE & ADMINISTRATION
- WARNINGS
- INDICATIONS & USAGE
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE TREATMENT
dermaline sulfur ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82165-108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLENE GLYCOL 2-PALMITATE (UNII: PD789E82CQ) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82165-108-02 70.9 g in 1 JAR; Type 0: Not a Combination Product 04/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 04/15/2022 Labeler - Dermaline USA corp (016069241)