FDA.reportPublic FDA data

Epionce Renewal Calming Cream

Manufacturer
Episciences, Inc.
Effective date
2022-09-20
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:53:23

Label at a glance#

ProductEpionce Renewal Calming Cream
Active ingredientOATMEAL
Label structure8 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 0.03%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve minor skin irritation and itching due to:
    • rashes
    • eczema

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll free 1-866-374-6623

Epionce Renewal Calming Cream Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8oz Box Front8oz Box Front

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42673-00042673-000-00, 42673-000-01, 42673-000-02, 42673-000-03, 42673-000-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEADOWFOAM SEED OIL412ZHA4T4YIACT
PETROLATUM4T6H12BN9UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SAFFLOWER OIL65UEH262ISIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
MAGNESIUM STEARATE70097M6I30IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERS137SL7IL0YIACT
OATMEAL8PI54V663YACTIB
PPG-2 MYRISTYL ETHER PROPIONATE88R97D8U8AIACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE NP4370DF050BIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
DOCOSANOL9G1OE216XYIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
WHITE WAX7G1J5DA97FIACT
ALLIUM FISTULOSUM BULBF8DD33CGGRIACT
APPLEB423VGH5S9IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CHOLESTEROL97C5T2UQ7JIACT
GLUCONOLACTONEWQ29KQ9POTIACT
CERAMIDE 15THT33P7X7IACT
TRISILOXANE9G1ZW13R0GIACT
EDETATE DISODIUM7FLD91C86KIACT
LEVOMENOL24WE03BX2TIACT
MAGNESIUM SALICYLATE41728CY7UXIACT
MANGANESE GLUCONATE9YY2F980SVIACT
NYMPHAEA ALBA FLOWER40KQ7Q535OIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
SODIUM PALMITOYL PROLINE64L053FRFOIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e9218bc1-d4a8-7c8d-e053-2995a90a4b9d696c1bf5-f46a-e7c6-e053-2a91aa0a671e2022-09-20WarningsExact identifier
spl id: e9218bc1-d4a8-7c8d-e053-2995a90a4b9d
spl set id: 696c1bf5-f46a-e7c6-e053-2a91aa0a671e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.