EPIONCE RENEWAL CALMING CREAM- oatmeal cream

Epionce Renewal Calming Cream by

Drug Labeling and Warnings

Epionce Renewal Calming Cream by is a Otc medication manufactured, distributed, or labeled by Episciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Colloidal Oatmeal 0.03%

Purpose

Skin Protectant

Uses

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

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

• apply as needed

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

INGREDIENTS AND APPEARANCE

EPIONCE RENEWAL CALMING CREAM 
oatmeal cream

Product 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)
DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SAFFLOWER OIL (UNII: 65UEH262IS)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
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)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
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)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
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)

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
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
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/28/2018

Labeler - Episciences, Inc. (144733040)

Establishment
Name	Address	ID/FEI	Business Operations
Episciences, Inc.		144733040	manufacture(42673-000)