Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 9b1dfb4b-ce35-46a1-bfc6-ee5b871955f3
Route
TOPICAL
Published
Effective Date 2020-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1 mg)
Inactive Ingredients
Olea Europaea (olive) Oil Unsaponifiables Almond Oil Honey Aloe Vera Leaf Yellow Wax Water Sodium Bicarbonate Potassium Sorbate Sunflower Oil Phenoxyethanol Ethylhexylglycerin Hexylene Glycol Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-24

Description

Active Ingredients: Colloidal Oatmeal 1%


Medication Information

Warnings and Precautions

Warning: For external use only.

Indications and Usage

Uses:

  • Temporarily protects and helps relieve minor skin irritation and itiching du to rashes and eczema. 
Dosage and Administration

Directions:

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

Active Ingredients: Colloidal Oatmeal 1%

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. Symptons last more than 7 days or clear up and appear again within a few days.

Section 50567-7

When using this product - do not get into eyes.

Section 51727-6

Inactive Ingredients: Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, hHoney, Aloe Barbadensis Leaf juice, Beeswax, Water (Aqua), Sodium Bicarbonate, Potassium Sorbate, Helianthus Annus (Sunflower) Seed Oil, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol.

Section 51945-4

Manufactured For

Eczema Honey CO LLC.

Hayward, CA, 94545

Section 53413-1

Questions or Comments?

Call toll free 707-652-3438

mail: [email protected]

Section 55105-1

Purpose: Skin Protectant

Section 55106-9

Active Ingredients:

Colloidal Oatmeal 1%

Section 60561-8

Other Information: Store below 30 C (68 F).


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Temporarily protects and helps relieve minor skin irritation and itiching du to rashes and eczema. 
Dosage and Administration (34068-7)

Directions:

  • Apply evenly to your skin. Apply lightly and use use 1-3 tomes 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. Symptons last more than 7 days or clear up and appear again within a few days.

Section 50567-7 (50567-7)

When using this product - do not get into eyes.

Section 51727-6 (51727-6)

Inactive Ingredients: Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, hHoney, Aloe Barbadensis Leaf juice, Beeswax, Water (Aqua), Sodium Bicarbonate, Potassium Sorbate, Helianthus Annus (Sunflower) Seed Oil, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol.

Section 51945-4 (51945-4)

Manufactured For

Eczema Honey CO LLC.

Hayward, CA, 94545

Section 53413-1 (53413-1)

Questions or Comments?

Call toll free 707-652-3438

mail: [email protected]

Section 55105-1 (55105-1)

Purpose: Skin Protectant

Section 55106-9 (55106-9)

Active Ingredients:

Colloidal Oatmeal 1%

Section 60561-8 (60561-8)

Other Information: Store below 30 C (68 F).


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)