Label: ZO SKIN HEALTH ACNE PREVENTION PLUS TREATMENT PROGRAM- sulfur kit
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Contains inactivated NDC Code(s)
NDC Code(s): 42851-175-85 - Packager: ZO Skin Health, 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 April 24, 2020
If you are a consumer or patient please visit this version.
- 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.
- 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 - Kit Carton
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH ACNE PREVENTION PLUS TREATMENT PROGRAM
sulfur kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-175 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-175-85 1 in 1 CARTON 01/17/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 200 mL Part 2 1 JAR 65 g Part 3 1 BOTTLE, GLASS 60 Part 4 1 TUBE 85 g Part 1 of 4 ZO SKIN HEALTH EXFOLIATING CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) INGR WATER (UNII: 059QF0KO0R) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR MANNITOL (UNII: 3OWL53L36A) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) INGR CAPRYLIC ALCOHOL (UNII: NV1779205D) INGR POWDERED CELLULOSE (UNII: SMD1X3XO9M) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) INGR AMMONIUM LACTATE (UNII: 67M901L9NQ) INGR NIACIN (UNII: 2679MF687A) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 200 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/17/2019 Part 2 of 4 ZO SKIN HEALTH EXFOLIATING POLISH
cleansing (cold creams, cleansing lotions, liquids, and pads) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR SODIUM BICARBONATE (UNII: 8MDF5V39QO) INGR MAGNESIUM OXIDE (UNII: 3A3U0GI71G) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR OLETH-20 (UNII: YTH167I2AG) INGR TRIHYDROXYSTEARIN (UNII: 06YD7896S3) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR TEA TREE OIL (UNII: VIF565UC2G) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR D&C GREEN NO. 6 (UNII: 4QP5U84YF7) INGR POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) INGR WATER (UNII: 059QF0KO0R) INGR MINERAL OIL (UNII: T5L8T28FGP) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR SOY STEROL (UNII: PL360EPO9J) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 65 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/17/2019 Part 3 of 4 ZO SKIN HEALTH COMPLEXION RENEWAL PADS
cleansing (cold creams, cleansing lotions, liquids, and pads) patchProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR WATER (UNII: 059QF0KO0R) INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR UREA (UNII: 8W8T17847W) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR GLYCOLIC ACID (UNII: 0WT12SX38S) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR PTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P) INGR PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8) INGR PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) INGR BARLEY (UNII: 5PWM7YLI7R) INGR CRITHMUM MARITIMUM (UNII: J7IHY79BKY) INGR ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) INGR .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/17/2019 Part 4 of 4 ZO SKIN HEALTH SULFUR MASQUE
sulfur creamProduct Information 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) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) CHLORPHENESIN (UNII: I670DAL4SZ) BENZYL ALCOHOL (UNII: LKG8494WBH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE SODIUM (UNII: MP1J8420LU) ULTRAMARINE BLUE (UNII: I39WR998BI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 01/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/17/2019 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 manufacture(42851-175) Establishment Name Address ID/FEI Business Operations Lifetech Resources, LLC. 081239587 manufacture(42851-175)
