SOTERI SKIN BABY ECZEMA RELIEF CREAM- colloidal oatmeal emulsion

Soteri Skin Baby Eczema Relief Cream by

Drug Labeling and Warnings

Soteri Skin Baby Eczema Relief Cream by is a Otc medication manufactured, distributed, or labeled by Soteri Skin, Inc, Creative Essences Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Colloidal Oatmeal 2%

Uses

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

Purpose

Skin Protectant

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 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, Glycerin, Helianthus Annuus (Sunflower) Oil, Cetearyl Alcohol, Cocos Nucifera
(Coconut) Oil, Lactobacillus Ferment, Ceteareth-20, Hydrolyzed Oat Protein, Dimethicone, Sodium Citrate, Niacinamide, 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.

Package Label

INGREDIENTS AND APPEARANCE

SOTERI SKIN BABY ECZEMA RELIEF CREAM 
colloidal oatmeal emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85265-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CHOLESTEROL (UNII: 97C5T2UQ7J)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM GLUCONATE (UNII: R6Q3791S76)
OAT (UNII: Z6J799EAJK)
GLUTAMIC ACID (UNII: 3KX376GY7L)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
LACTOBACILLUS (UNII: 5307V7XW8I)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
HISTIDINE (UNII: 4QD397987E)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-20 (UNII: YRC528SWUY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ASPARTIC ACID (UNII: 30KYC7MIAI)
CERAMIDE NP (UNII: 4370DF050B)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE AP (UNII: F1X8L2B00J)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85265-104-01	1 in 1 CARTON	10/23/2025
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	10/23/2025

Labeler - Soteri Skin, Inc (138344904)

Registrant - Creative Essences Inc (079120182)

Establishment
Name	Address	ID/FEI	Business Operations
Creative Essences Inc		079120182	manufacture(85265-104) , pack(85265-104) , label(85265-104)