EPIONCE RENEWAL CALMING CREAM- oatmeal cream 
Episciences, Inc.

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.

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Epionce Renewal Calming Cream

Active ingredient

Colloidal Oatmeal 0.03%

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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?

Call toll free 1-866-374-6623

Epionce Renewal Calming Cream Principal Display Panel

8oz Box Front

EPIONCE RENEWAL CALMING CREAM 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42673-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42673-000-011 in 1 BOX02/28/201812/31/2024
1NDC:42673-000-0030 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:42673-000-031 in 1 BOX02/28/201811/30/2024
2NDC:42673-000-02230 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:42673-000-046 g in 1 TUBE; Type 0: Not a Combination Product02/28/201812/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/28/201812/31/2024
Labeler - Episciences, Inc. (144733040)
Establishment
NameAddressID/FEIBusiness Operations
Episciences, Inc.144733040manufacture(42673-000)

Revised: 9/2022
Document Id: e9218bc1-d4a8-7c8d-e053-2995a90a4b9d
Set id: 696c1bf5-f46a-e7c6-e053-2a91aa0a671e
Version: 9
Effective Time: 20220920
 
Episciences, Inc.