315951e0-899f-c968-e063-6294a90abe61

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

Purpose

Purpose: Skin Protectan

Description

Active Ingredient: Colloidal Oatmeal 0.15%


Medication Information

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.

Uses

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

Purpose

Purpose: Skin Protectan

Directions

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

Other Information

Store at room temperature.

Inactive Ingredients

Porphyridium Conditioned Media, Phenoxyethanol.

Description

Active Ingredient: Colloidal Oatmeal 0.15%

Questions?

Call 760483-3626 or visit Porphose.com

Section 50565-1

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

Active Ingredient

Active Ingredient: Colloidal Oatmeal 0.15%

Purpose of Active Ingredient

Purpose: Skin Protectan

Porphose Eczema Relief Principal Display Panel


Structured Label Content

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.

Uses

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

Directions

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

Other Information

Store at room temperature.

Inactive Ingredients

Porphyridium Conditioned Media, Phenoxyethanol.

Questions?

Call 760483-3626 or visit Porphose.com

Section 50565-1 (50565-1)

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

Active Ingredient

Active Ingredient: Colloidal Oatmeal 0.15%

Purpose of Active Ingredient

Purpose: Skin Protectan

Porphose Eczema Relief Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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