SPL v1
SPL
SPL Set ID 315951e0-899f-c968-e063-6294a90abe61
Route
TOPICAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (0.15 g)
Inactive Ingredients
Phenoxyethanol Porphyridium Purpureum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-28

Description

Active Ingredient: Colloidal Oatmeal 0.15%

Purpose

Purpose: Skin Protectan


Medication Information

Purpose

Purpose: Skin Protectan

Description

Active Ingredient: Colloidal Oatmeal 0.15%

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rashes, poison ivy, poison oak, poison sumac, and insect bites.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only. Do not use on deep wounds, animal bites, or serious burns. When using this product do not get into eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if condition worsens, symptoms persist, or new irritation occurs.

Directions

Shake well before use. Apply as needed to affected areas.

Questions?

Call 760483-3626 or visit Porphose.com

Active Ingredient

Active Ingredient: Colloidal Oatmeal 0.15%

Other Information

Store at room temperature.

Inactive Ingredients

Porphyridium Conditioned Media, Phenoxyethanol.

Purpose of Active Ingredient

Purpose: Skin Protectan

Porphose Eczema Relief Principal Display Panel


Structured Label Content

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rashes, poison ivy, poison oak, poison sumac, and insect bites.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only. Do not use on deep wounds, animal bites, or serious burns. When using this product do not get into eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if condition worsens, symptoms persist, or new irritation occurs.

Directions

Shake well before use. Apply as needed to affected areas.

Questions?

Call 760483-3626 or visit Porphose.com

Active Ingredient

Active Ingredient: Colloidal Oatmeal 0.15%

Other Information

Store at room temperature.

Inactive Ingredients

Porphyridium Conditioned Media, Phenoxyethanol.

Purpose of Active Ingredient

Purpose: Skin Protectan

Porphose Eczema Relief Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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