SPL v2
SPL
SPL Set ID 5d65052d-2972-544d-e053-2a91aa0afa3e
Route
TOPICAL
Published
Effective Date 2017-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (0.02 g)
Inactive Ingredients
Cetyl Alcohol Ethylhexylglycerin Allantoin Glycyrrhizin Glyceryl 1-laurate Hydroxyethyl Behenamidopropyl Dimonium Chloride Sodium Hydroxide Hydroxypropyl Bispalmitamide Monoethanolamide Dexpanthenol Gluconolactone Cetostearyl Alcohol Dihexadecyl Phosphate Candelilla Wax Ceteth-10 Phosphate Edetic Acid Water Menthol, (+)- Isopropyl Myristate Avocado Oil Sodium Benzoate Glycerin Xanthan Gum Palmitic Acid Conjugated Linoleic Acid Cholesterol Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-02-01
Description

Active Ingredient Colloidal Oatmeal (Oat Kernel Flour) 2%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to

  • eczema
  • rash
  • dermatitis
Dosage and Administration

Directions

Apply as needed, especially after bathing. Massage thoroughly into skin as colloidal oatmeal is slow to absorb.

Description

Active Ingredient Colloidal Oatmeal (Oat Kernel Flour) 2%

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Section 50567-7

When using this product Do not get into eyes

Section 50569-3

Stop using and ask doctor if:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again wtihin a few days
Section 51727-6

Inactive ingredients

Purified Water, Cetyl Alcohol, Glycerin, Cetearyl Alcohol, Dicetylphosphate, Ceteth-10 Phosphate, Isopropyl Myristate, Persea Gratissima (Avocado) Oil, Glucono Delta Lactone, Glyceryl Monolaurate, D-Panthenol, Xanthan Gum, Hydroxypropyl Bispalmitamide MEA, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Palmitic Acid, Conjugated Linoleic Acid, Cholesterol, Euphorbia Cerifera (Candelilla) Wax, Phenoxyethanol, Ethylhexyl Glycerin, Allantoin, Glycyrrhizic Acid, Sodium Benzoate, Sodium Hydroxide, Menthol, Disodium EDTA

Section 51945-4

Section 53413-1

Questions or comments?

1-800-635-3696

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Colloidal Oatmeal (Oat Kernel Flour) 2%

Section 60561-8

Other Information

Keep cap tightly closed when not in use. Store at room temperature.

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to

  • eczema
  • rash
  • dermatitis
Dosage and Administration (34068-7)

Directions

Apply as needed, especially after bathing. Massage thoroughly into skin as colloidal oatmeal is slow to absorb.

Warnings and Precautions (34071-1)

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 immediately

Section 50567-7 (50567-7)

When using this product Do not get into eyes

Section 50569-3 (50569-3)

Stop using and ask doctor if:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again wtihin a few days
Section 51727-6 (51727-6)

Inactive ingredients

Purified Water, Cetyl Alcohol, Glycerin, Cetearyl Alcohol, Dicetylphosphate, Ceteth-10 Phosphate, Isopropyl Myristate, Persea Gratissima (Avocado) Oil, Glucono Delta Lactone, Glyceryl Monolaurate, D-Panthenol, Xanthan Gum, Hydroxypropyl Bispalmitamide MEA, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Palmitic Acid, Conjugated Linoleic Acid, Cholesterol, Euphorbia Cerifera (Candelilla) Wax, Phenoxyethanol, Ethylhexyl Glycerin, Allantoin, Glycyrrhizic Acid, Sodium Benzoate, Sodium Hydroxide, Menthol, Disodium EDTA

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-635-3696

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Colloidal Oatmeal (Oat Kernel Flour) 2%

Section 60561-8 (60561-8)

Other Information

Keep cap tightly closed when not in use. Store at room temperature.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.710544 · Updated: 2026-03-14T22:54:55.117494