Label: ZO SKIN HEALTH SULFUR MASQUE- sulfur cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42851-089-85 - Packager: ZO Skin Health, Inc.
- Category: HUMAN OTC DRUG LABEL
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 May 9, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Clean the skin thoroughly before applying this product.
- Cover the entire affected area with a thin layer twice a week.
- Suitable for use on face, chest, back or wherever breakouts occur.
- Leave on for 10-15 minutes and remove thoroughly with warm water, moist towels or cotton pads.
- If bothersome dryness or peeling occurs, reduce application frequency as directed by your doctor.
- As a spot treatment: apply a small amount onto the blemish and leave on overnight.
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH SULFUR MASQUE
sulfur creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-089 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 100 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TALC (UNII: 7SEV7J4R1U) KAOLIN (UNII: 24H4NWX5CO) GLYCERIN (UNII: PDC6A3C0OX) BENTONITE (UNII: A3N5ZCN45C) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE SODIUM (UNII: MP1J8420LU) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) BENZYL ALCOHOL (UNII: LKG8494WBH) ULTRAMARINE BLUE (UNII: I39WR998BI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-089-85 1 in 1 CARTON 02/22/2019 04/09/2022 1 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/22/2019 Labeler - ZO Skin Health, Inc. (826468527)