Soteri Skin Baby Eczema Relief Cream Ndc 85265-104

Soteri Skin Baby Eczema Relief Cream Ndc 85265-104
SPL v2
SPL
SPL Set ID 41d88ff2-22aa-8447-e063-6294a90aea0e
Route
TOPICAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (2 g)
Inactive Ingredients
Cholesterol 1,2-hexanediol Dimethicone Sodium Gluconate Oat Glutamic Acid Sodium Lauroyl Lactylate Lactobacillus Glycerin Niacinamide Histidine Xanthan Gum Edetate Disodium Cetearyl Alcohol Ceteareth-20 Anhydrous Citric Acid Caprylyl Glycol Aspartic Acid Ceramide Np Water Phenoxyethanol Ceramide 1 Ceramide Ap Butyrospermum Parkii (shea) Butter Helianthus Annuus (sunflower) Seed Oil Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-23

Description

Colloidal Oatmeal 2%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Colloidal Oatmeal 2%

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 a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Directions
  • Apply twice per day, AM and PM and always after cleansing.
  • Apply as needed.
Package Label

Active Ingredient

Colloidal Oatmeal 2%

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.

Keep Out of Reach of Children

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


Structured Label Content

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

Active Ingredient

Colloidal Oatmeal 2%

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.

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.


Advanced Ingredient Data


Raw Label Data

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