![ZO SKIN HEALTH GSR (GETTING SKIN READY) SYSTEM (SALICYLIC ACID) KIT [ZO SKIN HEALTH, INC.]](https://medic.hrt.org//dailymed/images/a82129fc-0b0d-4ade-96cd-94917caac930/zo-skin-01.jpg)
| NDC | 42851-078-07, 42851-172-07 |
| Set ID | a82129fc-0b0d-4ade-96cd-94917caac930 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | ZO Skin Health, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART333D |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Sunburn Alert
- Other information
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Inactive ingredients
Water, Alcohol Denat., Propylene Glycol, Urea, Sodium Hydroxide, Fragrance, Glycolic Acid, Butylene Glycol, Denatonium Benzoate, t-Butyl Alcohol, Sodium Chloride, Sodium Carbonate, Spiraea Ulmaria Extract, Pterocarpus Santalinus Wood Extract, Plantago Major Leaf Extract, Phellodendron Amurense Bark Extract, Hordeum Vulgare Seed Extract, Crithmum Maritimum Extract, Camellia Sinensis Leaf Oil, Artemisia Vulgaris Extract, Phenoxyethanol.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH GSR (GETTING SKIN READY) SYSTEM
salicylic acid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-172 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-172-07 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 40 mL Part 2 1 JAR 16.2 g Part 3 1 BOTTLE, GLASS 75 mL Part 1 of 3 OFFECTS EXFOLIATING CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity 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 CHLORIDE (UNII: 451W47IQ8X) 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 AMMONIUM LACTATE (UNII: 67M901L9NQ) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) INGR TEA TREE OIL (UNII: VIF565UC2G) INGR NIACIN (UNII: 2679MF687A) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SODIUM GLYCOLATE (UNII: B75E535IMI) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR HYPROMELLOSES (UNII: 3NXW29V3WO) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 40 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 Part 2 of 3 OFFECTS EXFOLIATING POLISH
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) INGR SODIUM BICARBONATE (UNII: 8MDF5V39QO) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR MAGNESIUM OXIDE (UNII: 3A3U0GI71G) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR OLETH-20 (UNII: YTH167I2AG) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 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 PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR SOY STEROL (UNII: PL360EPO9J) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR D&C GREEN NO. 6 (UNII: 4QP5U84YF7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16.2 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 Part 3 of 3 OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM
salicylic acid solutionProduct Information Item Code (Source) NDC:42851-078 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) UREA (UNII: 8W8T17847W) DALTEPARIN SODIUM (UNII: 12M44VTJ7B) GLYCOLIC ACID (UNII: 0WT12SX38S) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) SANDALWOOD (UNII: 3641YW25N2) PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) BARLEY (UNII: 5PWM7YLI7R) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) PHENOXYETHANOL (UNII: HIE492ZZ3T) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-078-07 75 mL 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 OTC MONOGRAPH FINAL part333D 01/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/01/2011 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Lifetech Resources 622559110 MANUFACTURE(42851-172)
