Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID b5eb48a5-e884-3bf6-e053-2a95a90abb97
Route
TOPICAL
Published
Effective Date 2020-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1 mg)
Inactive Ingredients
Potassium Sorbate Caprylyl Glycol Ethylhexylglycerin Phenoxyethanol Hexylene Glycol Water Grape Seed Oil Aloe Vera Leaf Yellow Wax Honey Sodium Bicarbonate Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-07
Description

Active Ingredient: Colloidal Oatmeal 1.0%

Medication Information

Warnings and Precautions

Warning:

  • For external use only.
Indications and Usage

Uses:

  • Temporarily protects and helps relieve minor skin iritation and itching due to rashes and eczema.
Dosage and Administration

Directions:

Apply evenly to your skin. Apply lightly and use 1-3 times a day as needed.

Description

Active Ingredient: Colloidal Oatmeal 1.0%

Section 50565-1

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9

Stop use and ask a Doctor if:

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within few days
Section 50567-7

When using this product - do not get into eyes.

Section 51727-6

Vitis Vinifera (Grape) Seed Oil, Honey*, Aloe Barbadensis Leaf Juice*, Beeswax, Helianthus Annus (sunflower) seed oil*, Water (Aqua), Sodium Bicarbonate, Phenoxyethanol, Potassium Sorbate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol

* Refers to Certified Organics.

Section 51945-4

Manufactured for:

Eczema Honey Co, LLC

Hayward CA-94544

Section 53413-1

Questions or comments?

Call to toll free number (707) 652-3438

email: [email protected]

Section 55105-1

Purpose: Skin Protectant

Section 55106-9

Active Ingredient: Colloidal Oatmeal 1.0%

Section 60561-8

Other Information:

Store Below 30ºC. (86ºF)

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Temporarily protects and helps relieve minor skin iritation and itching due to rashes and eczema.
Dosage and Administration (34068-7)

Directions:

Apply evenly to your skin. Apply lightly and use 1-3 times a day as needed.

Warnings and Precautions (34071-1)

Warning:

  • For external use only.
Section 50565-1 (50565-1)

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)

Stop use and ask a Doctor if:

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within few days
Section 50567-7 (50567-7)

When using this product - do not get into eyes.

Section 51727-6 (51727-6)

Vitis Vinifera (Grape) Seed Oil, Honey*, Aloe Barbadensis Leaf Juice*, Beeswax, Helianthus Annus (sunflower) seed oil*, Water (Aqua), Sodium Bicarbonate, Phenoxyethanol, Potassium Sorbate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol

* Refers to Certified Organics.

Section 51945-4 (51945-4)

Manufactured for:

Eczema Honey Co, LLC

Hayward CA-94544

Section 53413-1 (53413-1)

Questions or comments?

Call to toll free number (707) 652-3438

email: [email protected]

Section 55105-1 (55105-1)

Purpose: Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient: Colloidal Oatmeal 1.0%

Section 60561-8 (60561-8)

Other Information:

Store Below 30ºC. (86ºF)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:39.374041 · Updated: 2026-03-14T23:05:33.999008