Label: EPIONCE RENEWAL CALMING CREAM- oatmeal cream
-
NDC Code(s):
42673-000-00,
42673-000-01,
42673-000-02,
42673-000-03, view more42673-000-04
- Packager: Episciences, 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 September 20, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
-
Inactive ingredients
Water, Glycerin, Petrolatum, Meadowfoam Seed Oil, Safflower Oil, PPG-2 Myristyl Ether Propionate, Hydrogenated Polybutene (1300MW), Cyclomethicone 5, Rosa Canina Fruit Oil, White Wax, Gluconolactone, Allium Fistulosum Bulb, Alteromonas Ferment Filtrate, Apple, Arachidyl Alcohol, Arachidyl Glucoside, Butylene Glycol, C10-30 Cholesterol/Lanosterol Esters, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Carboxypolymethylene, Ceramide 1, Ceramide AP, Ceramide NP, Cetearyl Glucoside, Cetostearyl Alcohol, Cetyl Alcohol, Cholesterol, Cyclomethicone 4, Cyclomethicone 6, Dimethiconol (14000 CST), Docosanol, Edetate Disodium, Glyceryl Monostearate, Levomenol, Magnesium Salicylate, Magnesium Stearate, Manganese Gluconate, Meadowfoam Estolide, Nymphaea Alba Flower, PEG-100 Stearate, Phytosphingosine, Sodium Benzoate, Sodium Lauroyl Lactylate, Sodium Palmitoyl Proline, Trolamine, Xanthan Gum, Zinc Stearate.
- Questions?
- Epionce Renewal Calming Cream Principal Display Panel
-
INGREDIENTS AND APPEARANCE
EPIONCE RENEWAL CALMING CREAM
oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42673-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.03 g in 1 g Inactive Ingredients Ingredient Name Strength MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) PETROLATUM (UNII: 4T6H12BN9U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SAFFLOWER OIL (UNII: 65UEH262IS) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) MAGNESIUM STEARATE (UNII: 70097M6I30) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) CERAMIDE AP (UNII: F1X8L2B00J) CERAMIDE NP (UNII: 4370DF050B) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CETYL ALCOHOL (UNII: 936JST6JCN) DOCOSANOL (UNII: 9G1OE216XY) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) WHITE WAX (UNII: 7G1J5DA97F) ALLIUM FISTULOSUM BULB (UNII: F8DD33CGGR) APPLE (UNII: B423VGH5S9) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CHOLESTEROL (UNII: 97C5T2UQ7J) GLUCONOLACTONE (UNII: WQ29KQ9POT) CERAMIDE 1 (UNII: 5THT33P7X7) TRISILOXANE (UNII: 9G1ZW13R0G) EDETATE DISODIUM (UNII: 7FLD91C86K) LEVOMENOL (UNII: 24WE03BX2T) MAGNESIUM SALICYLATE (UNII: 41728CY7UX) MANGANESE GLUCONATE (UNII: 9YY2F980SV) NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO) TROLAMINE (UNII: 9O3K93S3TK) XANTHAN GUM (UNII: TTV12P4NEE) ZINC STEARATE (UNII: H92E6QA4FV) PHENOXYETHANOL (UNII: HIE492ZZ3T) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42673-000-01 1 in 1 BOX 02/28/2018 12/31/2024 1 NDC:42673-000-00 30 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:42673-000-03 1 in 1 BOX 02/28/2018 11/30/2024 2 NDC:42673-000-02 230 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:42673-000-04 6 g in 1 TUBE; Type 0: Not a Combination Product 02/28/2018 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/28/2018 12/31/2024 Labeler - Episciences, Inc. (144733040) Establishment Name Address ID/FEI Business Operations Episciences, Inc. 144733040 manufacture(42673-000)
