NDC | 42851-080-12 |
Set ID | 376f2589-d8da-4278-a46b-3e4778bee035 |
Category | HUMAN OTC DRUG LABEL |
Packager | ZO Skin Health, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Water, Isopropyl Isostearate, Glycerin, Petrolatum, Dimethicone, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Beta-Glucan, PEG-100 Stearate, Glyceryl Stearate, Steareth-21, Polymethyl Methacrylate, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzalkonium Chloride, Aminomethyl Propanol, Butylene Glycol, Myristoyl Pentapeptide-11, Tocopheryl Acetate, Tetrapeptide-21, Retinyl Palmitate, Ascorbic Acid.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 120 mL Tube Label
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INGREDIENTS AND APPEARANCE
ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT
oatmeal lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-080 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) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) SHEANUT OIL (UNII: O88E196QRF) CURDLAN (UNII: 6930DL209R) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARETH-21 (UNII: 53J3F32P58) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TETRAPEPTIDE-21 (UNII: 179JUC43HU) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBIC ACID (UNII: PQ6CK8PD0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-080-12 120 mL in 1 TUBE; Type 0: Not a Combination Product 11/14/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 11/14/2014 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations PakLab 790530976 MANUFACTURE(42851-080)