SPL v4
SPL
SPL Set ID 9f211875-4ffb-493d-a011-40c3a2b86615
Route
TOPICAL
Published
Effective Date 2011-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (2.3 g)
Inactive Ingredients
Butylated Hydroxytoluene Cetyl Alcohol Coccinia Grandis Fruit Propylene Glycol Azadirachta Indica Leaf Sesame Oil Sodium Lauryl Sulfate Methylparaben Sodium Propylparaben Sodium Stearic Acid Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-01-02
Description

Colloidal Oatmeal 2%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

  • eczema
  • rashes

  • insect bites

  • poison ivy, oak or sumac
Dosage and Administration

Directions

  • apply twice a day or as needed
Description

Colloidal Oatmeal 2%

Section 44425-7

Other Information

  • store in a cool and dry place
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 a few days

Section 50567-7

When using this product

  • do not get into eyes
  • if you currently use steroids or have used steroids in the recent past, it may take 1 to 3 months to see results

Section 50570-1

Do not use if you are allergic to sesame oil.

Section 51727-6

Inactive Ingredients

BHT, Cetyl Alcohol, Coccinia Indica fruit extract, Fragrance, Holarrhena Atidysenterica leaf extract, Melia Azadirachta leaf extract, Propylene Glycol, Sesamum Indicum (Sesame) seed oil, Sodium Lauryl Sulfate, Sodium Methylparaben, Sodium Propylbaraben, Stearic Acid, White soft paraffin

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Colloidal Oatmeal 2%

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

  • eczema
  • rashes

  • insect bites

  • poison ivy, oak or sumac
Dosage and Administration (34068-7)

Directions

  • apply twice a day or as needed
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 44425-7 (44425-7)

Other Information

  • store in a cool and dry place
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 a few days

Section 50567-7 (50567-7)

When using this product

  • do not get into eyes
  • if you currently use steroids or have used steroids in the recent past, it may take 1 to 3 months to see results

Section 50570-1 (50570-1)

Do not use if you are allergic to sesame oil.

Section 51727-6 (51727-6)

Inactive Ingredients

BHT, Cetyl Alcohol, Coccinia Indica fruit extract, Fragrance, Holarrhena Atidysenterica leaf extract, Melia Azadirachta leaf extract, Propylene Glycol, Sesamum Indicum (Sesame) seed oil, Sodium Lauryl Sulfate, Sodium Methylparaben, Sodium Propylbaraben, Stearic Acid, White soft paraffin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Colloidal Oatmeal 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:23.763932 · Updated: 2026-03-14T22:52:57.217022