M3 Naturals: Eczema Cream

M3 Naturals: Eczema Cream
SPL v2
SPL
SPL Set ID 45e2cdde-58fb-4eea-a54d-f53f9ad0d854
Route
TOPICAL
Published
Effective Date 2021-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (10 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Water Shea Butter Calendula Officinalis Flower Cannabis Sativa Seed Oil Medium-chain Triglycerides Carthamus Tinctorius Flower Oil Chamomile Cucumber Emu Oil Ethylhexylglycerin Glucosamine Sulfate Glycerin Glyceryl Monostearate Licorice Helianthus Annuus Flowering Top Phenoxyethanol Pomegranate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-19
Description

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Colloidal Oatmeal 1%

Warnings:

■ For external use only.  ■ Avoid contact with eyes.

Directions:
  • Adults and children two-years of age or older: Apply as needed
  • Children under two-years of age: consult a physician.
Drug Facts:

Indications:

Temporarily protects and helps relieve minor skin irritation and itching due to ■ Eczema or ■ rashes.

Active Ingredient

Colloidal Oatmeal 1%

Package Labeling:

Other Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Organic Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

Additional Information:

for use on mild to moderate Eczema or as directed by physician. Store at room temperature.

Stop Use and Ask A Doctor If:
  • condition worsens,
  • symptoms last for more than 7 days, or clear up and occur again within a few days.
Keep Out of Reach of Children.
  • If swallowed, consult physician.

Structured Label Content

Purpose

Skin Protectant

Warnings:

■ For external use only.  ■ Avoid contact with eyes.

Directions:
  • Adults and children two-years of age or older: Apply as needed
  • Children under two-years of age: consult a physician.
Drug Facts:

Indications:

Temporarily protects and helps relieve minor skin irritation and itching due to ■ Eczema or ■ rashes.

Active Ingredient

Colloidal Oatmeal 1%

Package Labeling:

Other Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Organic Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

Additional Information:

for use on mild to moderate Eczema or as directed by physician. Store at room temperature.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • condition worsens,
  • symptoms last for 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, consult physician.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:19.905080 · Updated: 2026-03-14T23:01:48.065872