SOTERI SKIN ACTIVE FLARE-UP ECZEMA RELIEF CREAM- colloidal oatmeal emulsion

Soteri Skin Active Flare-Up Eczema Relief Cream by

Drug Labeling and Warnings

Soteri Skin Active Flare-Up Eczema Relief Cream by is a Otc medication manufactured, distributed, or labeled by Soteri Skin, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Colloidal Oatmeal 1.5%

Purpose

Skin Protectant

Uses

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

Warnings

For external use only

When using this product

• do not get into eyes

Stop use and ask 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply twice per day, AM and PM and always after cleansing.
• Apply as needed.

Inactive Ingredients

Purified Water, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Oil, Glycerin, Cetearyl Alcohol, Ceteareth-20, Lactobacillus Ferment, Dimethicone, Hydrolyzed Oat Protein, Sodium Citrate, Camellia Sinensis Leaf Extract, Niacinamide, Glyceryl Laurate, Glutamic Acid, Aspartic Acid, Histidine, Citric Acid, Sodium Gluconate, Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Sodium Lauroyl Lactylate, Cholesterol, Xanthan Gum, Caprylyl Glycol, 1,2-Hexanediol, Phenoxyethanol, Disodium EDTA.

Other Information

Store below 30C (86F)

Package Label PDP

INGREDIENTS AND APPEARANCE

SOTERI SKIN ACTIVE FLARE-UP ECZEMA RELIEF CREAM 
colloidal oatmeal emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85265-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
CETEARETH-20 (UNII: YRC528SWUY)
OAT AMINO ACIDS (UNII: NU3FAK86IP)
LACTOBACILLUS (UNII: 5307V7XW8I)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERYL LAURATE (UNII: Y98611C087)
GLUTAMIC ACID (UNII: 3KX376GY7L)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HISTIDINE (UNII: 4QD397987E)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CERAMIDE AP (UNII: F1X8L2B00J)
ASPARTIC ACID (UNII: 30KYC7MIAI)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85265-102-01	1 in 1 CARTON	10/21/2025
1		100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/21/2025

Labeler - Soteri Skin, Inc. (138344904)