Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2f2de819-b7db-4c1e-9d6e-9ce33f7e6d05
Route
TOPICAL
Published
Effective Date 2025-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (10 mg)
Inactive Ingredients
Water Sunflower Oil Propanediol Glyceryl Monostearate Glycerin Lactobacillus Acidophilus C13-15 Alkane Cetyl Alcohol Calendula Officinalis Whole Padina Pavonica Betasizofiran Comfrey Leaf Coconut Sodium Benzoate Haberlea Rhodopensis Leaf Potassium Sorbate Anhydrous Citric Acid Cedrus Deodara Wood Oil Phytate Sodium Xanthan Gum Hyaluronate Sodium Shea Butter Ceramide Np Moringa Oleifera Seed Oil Phytosphingosine Meadowfoam Seed Oil Macadamia Oil Hydrogenated Soybean Lecithin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-19

Description

Colloidal Oatmeal 1%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Colloidal Oatmeal 1%

Use

Temporarily protects and helps relieve minor skin irritation due to

  • eczema
  • rashes
Section 50566-9
  • stop use and consult a doctor if condition worsens or symptoms last more than seven days or clear up and occur again within a few days.
Warnings

For external use only.

Directions

Use as needed.

Questions?

Email [email protected] or call 1-855-263-3980

Steroid Free

Microbiome Friendly

Active Ingredient

Colloidal Oatmeal 1%

Inactive Ingredients

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Glyceryl Stearate, Glycerin, Lactobacillus Ferment, C13-15 Alkane, Cetyl Alcohol, Lactobacillus, Calendula Officinalis Meristem Cell Extract, Haberlea Rhodopensis Leaf Extract, Padina Pavonica Thallus Extract, Symphytum Officinale (Comfrey) Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Moringa Oleifera Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Macadamia Integrifolia Seed Oil, Cedrus Deodara (Cedarwood) Wood Oil, Hydrogenated Lecithin, Phytosphingosine, Hydrolyzed Sodium Hyaluronate, Ceramide NP, Sodium Phytate, Sclerotium Gum, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, Citric Acid

When Using This Product
  • do not get into eyes
Keep Out of Reach of Children.

If swallowed get medical help or contact a poison control center immediately.

Principal Display Panel – 100 Ml Carton Label

CODEX

LABS

BIA

ECZEMA RELIEF LOTION

Skin Protectant

Colloidal Oatmeal 1%

3.4 FL. OZ. / 100 mL ℮


Structured Label Content

Use

Temporarily protects and helps relieve minor skin irritation due to

  • eczema
  • rashes
Section 50566-9 (50566-9)
  • stop use and consult a doctor if condition worsens or symptoms last more than seven days or clear up and occur again within a few days.
Purpose

Skin Protectant

Warnings

For external use only.

Directions

Use as needed.

Questions?

Email [email protected] or call 1-855-263-3980

Steroid Free

Microbiome Friendly

Active Ingredient (Active ingredient)

Colloidal Oatmeal 1%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Glyceryl Stearate, Glycerin, Lactobacillus Ferment, C13-15 Alkane, Cetyl Alcohol, Lactobacillus, Calendula Officinalis Meristem Cell Extract, Haberlea Rhodopensis Leaf Extract, Padina Pavonica Thallus Extract, Symphytum Officinale (Comfrey) Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Moringa Oleifera Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Macadamia Integrifolia Seed Oil, Cedrus Deodara (Cedarwood) Wood Oil, Hydrogenated Lecithin, Phytosphingosine, Hydrolyzed Sodium Hyaluronate, Ceramide NP, Sodium Phytate, Sclerotium Gum, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, Citric Acid

When Using This Product (When using this product)
  • do not get into eyes
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed get medical help or contact a poison control center immediately.

Principal Display Panel – 100 Ml Carton Label (Principal Display Panel – 100 mL Carton Label)

CODEX

LABS

BIA

ECZEMA RELIEF LOTION

Skin Protectant

Colloidal Oatmeal 1%

3.4 FL. OZ. / 100 mL ℮


Advanced Ingredient Data


Raw Label Data

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