SPL v1
SPL
SPL Set ID 4b2bba1b-7e7b-4397-9eb4-d94c44b98314
Route
TOPICAL
Published
Effective Date 2025-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (5 g)
Inactive Ingredients
Water Aloe Vera Leaf Juice Glycerin Allantoin Chamomile Amino Acids, Oat Tocopherol Panthenol Cucumber Sodium Pyrrolidone Carboxylate Phenoxyethanol Citric Acid Monohydrate Glycyrrhiza Glabra (licorice) Root Powder Calendula Officinalis Flower Shea Butter Jojoba Oil Niacinamide Hyaluronate Sodium Witch Hazel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-03

Description

Colloidal Oatmeal 5% 

Purpose

Soothing and anti-inflammatory


Medication Information

Purpose

Soothing and anti-inflammatory

Description

Colloidal Oatmeal 5% 

Uses

Controls scaling, dryness, itching, and irritation associated with psoriasis.

Section 50565-1

Warnings

Do not use:

• On severe burns or sunburned skin.

• If you are allergic to ingredients in this product.

When using this product:

• Avoid contact with eyes.

• If contact occurs, rinse the eyes thoroughly with water.

• If using hydrocortisone, follow dosage instructions.

Stop use and ask a doctor if:

• Rash appears.

• Condition worsens or does not improve in 2-4 weeks.

If pregnant or breast-feeding, ask a doctor before use.

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

Directions

Adults and children aged 12 and over.

  • Wet skin thoroughly.
  • Apply a generous amount of gel to damp skin.
  • Gently massage onto affected areas in circular motions.
  • Rinse thoroughly with water.
  • Follow with a moisturizer or prescribed treatment as needed or as directed by your physician.

For optimal results, use daily or as recommended by your dermatologist

Children under 12 years old.

  •  Ask a doctor.
Product Label

Active Ingredient

Colloidal Oatmeal 5% 

Other Information 

• Store in a cool, dry place away from direct sunlight.

• Keep the dispenser tightly closed when not in use to maintain product quality.

• Keep out of reach of children.

Inactive Ingredients

Water, Aloe Vera Leaf Juice, Glycerin, Allantoin, Chamomile Extract, Oat Amino Acids (Hydrolyzed Oat Protein), Tocopherol (Vitamin E), Panthenol, Cucumber Extract, Sodium PCA, Phenoxyethanol, Citric Acid, Licorice Extract, Calendula Officinalis Extract, Shea Butter, Jojoba Oil, Niacinamide, Sodium Hyaluronate, Witch Hazel Extract


Structured Label Content

Uses

Controls scaling, dryness, itching, and irritation associated with psoriasis.

Section 50565-1 (50565-1)

Purpose

Soothing and anti-inflammatory

Warnings

Do not use:

• On severe burns or sunburned skin.

• If you are allergic to ingredients in this product.

When using this product:

• Avoid contact with eyes.

• If contact occurs, rinse the eyes thoroughly with water.

• If using hydrocortisone, follow dosage instructions.

Stop use and ask a doctor if:

• Rash appears.

• Condition worsens or does not improve in 2-4 weeks.

If pregnant or breast-feeding, ask a doctor before use.

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

Directions

Adults and children aged 12 and over.

  • Wet skin thoroughly.
  • Apply a generous amount of gel to damp skin.
  • Gently massage onto affected areas in circular motions.
  • Rinse thoroughly with water.
  • Follow with a moisturizer or prescribed treatment as needed or as directed by your physician.

For optimal results, use daily or as recommended by your dermatologist

Children under 12 years old.

  •  Ask a doctor.
Product Label (Product label)

Active Ingredient

Colloidal Oatmeal 5% 

Other Information 

• Store in a cool, dry place away from direct sunlight.

• Keep the dispenser tightly closed when not in use to maintain product quality.

• Keep out of reach of children.

Inactive Ingredients (Inactive ingredients)

Water, Aloe Vera Leaf Juice, Glycerin, Allantoin, Chamomile Extract, Oat Amino Acids (Hydrolyzed Oat Protein), Tocopherol (Vitamin E), Panthenol, Cucumber Extract, Sodium PCA, Phenoxyethanol, Citric Acid, Licorice Extract, Calendula Officinalis Extract, Shea Butter, Jojoba Oil, Niacinamide, Sodium Hyaluronate, Witch Hazel Extract


Advanced Ingredient Data


Raw Label Data

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