Label: ZO MEDICAL 3-STEP PEEL KIT- oatmeal kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 42851-083-56, 42851-190-56 - 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 3, 2018
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 ingredient
- Purpose
- Uses
- Warnings
- Directions
-
Inactive ingredients
Water, Glycerin, Petrolatum, Distearyldimonium Chloride, Isopropyl Palmitate, Cyclopentasiloxane, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Benzyl Alcohol, Polymethyl Methacrylate, Dipotassium Glycyrrhizate, Benzalkonium Chloride, Butylene Glycol, Tocopheryl Acetate, Pentylene Glycol, 1,2-Hexanediol, Sodium Chloride, Alcohol, Isopropyl Alcohol, Beta-Glucan, Retinyl Palmitate, Ascorbic Acid, Dibenzyl Ether, Tetrapeptide-21, Myristoyl Pentapeptide-11.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
ZO MEDICAL 3-STEP PEEL KIT
oatmeal kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-190 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-190-56 1 in 1 CARTON 12/01/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 BOTTLE, DISPENSING 48 mL Part 2 12 PACKET 30 g Part 3 6 TUBE 348 mL Part 1 of 3 ZO MEDICAL PEEL
cleansing (cold creams, cleansing lotions, liquids, and pads) solutionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Alcohol (UNII: 3K9958V90M) INGR Salicylic Acid (UNII: O414PZ4LPZ) INGR Trichloroacetic Acid (UNII: 5V2JDO056X) INGR Water (UNII: 059QF0KO0R) INGR LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR TERT-BUTYL ALCOHOL (UNII: MD83SFE959) INGR Denatonium Benzoate (UNII: 4YK5Z54AT2) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 12/01/2016 Part 2 of 3 ZO MEDICAL RETINOL CREME COMPLEX
cleansing (cold creams, cleansing lotions, liquids, and pads) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR Retinol (UNII: G2SH0XKK91) INGR Glycerin (UNII: PDC6A3C0OX) INGR ALLYL METHACRYLATE (UNII: G2IG50653Z) INGR Stearyl Alcohol (UNII: 2KR89I4H1Y) INGR Polysorbate 60 (UNII: CAL22UVI4M) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR Palmitic Acid (UNII: 2V16EO95H1) INGR UBIDECARENONE (UNII: EJ27X76M46) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR Hydrogenated Jojoba Oil (UNII: 7F674YQ5SO) INGR GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR Stearic Acid (UNII: 4ELV7Z65AP) INGR LEVOMENOL (UNII: 24WE03BX2T) INGR Ascorbic Acid (UNII: PQ6CK8PD0R) INGR Sorbitol (UNII: 506T60A25R) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR HEXAMETHYLCYCLOTRISILOXANE (UNII: EPV75L8O0R) INGR CYCLOMETHICONE 4 (UNII: CZ227117JE) INGR CYCLOMETHICONE 6 (UNII: XHK3U310BA) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR SAFFLOWER OIL (UNII: 65UEH262IS) INGR CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) INGR Xanthan Gum (UNII: TTV12P4NEE) INGR Hexylene Glycol (UNII: KEH0A3F75J) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Caprylyl Glycol (UNII: 00YIU5438U) INGR BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) INGR DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) INGR APPLE FRUIT OIL (UNII: 9NT987I3A8) INGR Myristic Acid (UNII: 0I3V7S25AW) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2.5 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 12/01/2016 Part 3 of 3 REVITATROL EPIDERMAL REPAIR SKIN PROTECTANT
oatmeal lotionProduct Information Item Code (Source) NDC:42851-083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Petrolatum (UNII: 4T6H12BN9U) Distearyldimonium Chloride (UNII: OM9573ZX3X) Isopropyl Palmitate (UNII: 8CRQ2TH63M) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Cetyl Alcohol (UNII: 936JST6JCN) SHEA BUTTER (UNII: K49155WL9Y) Benzyl Alcohol (UNII: LKG8494WBH) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) Benzalkonium Chloride (UNII: F5UM2KM3W7) Butylene Glycol (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Pentylene Glycol (UNII: 50C1307PZG) 1,2-Hexanediol (UNII: TR046Y3K1G) Sodium Chloride (UNII: 451W47IQ8X) Alcohol (UNII: 3K9958V90M) Isopropyl Alcohol (UNII: ND2M416302) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Ascorbic Acid (UNII: PQ6CK8PD0R) Dibenzyl Ether (UNII: 2O6CNO27RJ) Tetrapeptide-21 (UNII: 179JUC43HU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-083-56 58 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 OTC MONOGRAPH FINAL part347 12/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 12/01/2016 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(42851-190) Establishment Name Address ID/FEI Business Operations PakLab 790530976 MANUFACTURE(42851-190)
