Soteri Skin Active Flare-up Eczema Relief Cream 100 Ml / 3.4 Fl Oz (ndc 85265-102-01)

Soteri Skin Active Flare-up Eczema Relief Cream 100 Ml / 3.4 Fl Oz (ndc 85265-102-01)
SPL v2
SPL
SPL Set ID 41b558d9-55ba-97ff-e063-6394a90a963b
Route
TOPICAL
Published
Effective Date 2025-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1.5 g)
Inactive Ingredients
Aqua Helianthus Annuus (sunflower) Seed Oil Ceteareth-20 Oat Amino Acids Lactobacillus Dimethicone Cetearyl Alcohol Niacinamide Glyceryl Laurate Glutamic Acid Sodium Citrate Anhydrous Citric Acid Xanthan Gum Phenoxyethanol Butyrospermum Parkii (shea) Butter Glycerin Camellia Sinensis Leaf Caprylyl Glycol Histidine Phytosphingosine Sodium Lauroyl Lactylate Cholesterol 1,2-hexanediol Edetate Disodium Ceramide Ap Aspartic Acid Sodium Gluconate Ceramide Np Ceramide 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-21
Description

Colloidal Oatmeal 1.5%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Colloidal Oatmeal 1.5%

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

Colloidal Oatmeal 1.5%

Other Information

Store below 30C (86F)

Package Label Pdp

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.

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.

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 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.
Active Ingredient

Colloidal Oatmeal 1.5%

Other Information

Store below 30C (86F)

Package Label Pdp (Package Label PDP)

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.

Keep Out of Reach of Children (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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:36.742326 · Updated: 2026-03-14T23:11:14.961491