SPL v3
SPL
SPL Set ID 60a66a9f-6f72-0b89-e053-2a91aa0a6cce
Route
TOPICAL
Published
Effective Date 2017-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1.5 g)
Inactive Ingredients
Calcium Gluconate Citric Acid Monohydrate Coconut Oil Aloe Vera Leaf Glycerin Water Glyceryl Stearate Se Xanthan Gum Sodium Benzoate Disodium Cocoyl Glutamate Gluconolactone Sodium Chloride Linseed Oil Glyceryl Laurate Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-02-08
Description

Active Ingredient Colloidal Oatmeal - 1.5%

Medication Information

Warnings and Precautions

For external use only. Avoid contacts with eyes. Stop use and ask a doctor if symptoms last more than 7 days or condition worsens.

Indications and Usage

Gentle cleanses skin and helps relieve minor skin irritation and iching due to eczema, rashes, dry skin.

Dosage and Administration

Massage cleanser over damp face and body, rinse clean, pat dry. Following immediately with an Eczema Relief cream locks in moisture.

Description

Active Ingredient Colloidal Oatmeal - 1.5%

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact Poison Center immediately.

Section 51727-6

Water, Aloe Barbadensis Leaf Juice(1), Disodium Cocoyl Glutamate, Glyceryl Laurate, Glycerin, Glyceryl Stearate SE, Stearyl Alcohol, Cocos Nucifera (Coconut) Oil (1), Sodium Laurylglucosides Hydroxypropylsulfonate, Xanthan Gum, Linum Usatatissimum (Linseed) Seed Oil (1), Gluconolactone, Calcium Gluconate, Citric Acid, Sodium Chloride, Sodium Benzoate.

(1) Certified Organicf Ingredient

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Active Ingredient

Colloidal Oatmeal - 1.5%

Structured Label Content

Indications and Usage (34067-9)

Gentle cleanses skin and helps relieve minor skin irritation and iching due to eczema, rashes, dry skin.

Dosage and Administration (34068-7)

Massage cleanser over damp face and body, rinse clean, pat dry. Following immediately with an Eczema Relief cream locks in moisture.

Warnings and Precautions (34071-1)

For external use only. Avoid contacts with eyes. Stop use and ask a doctor if symptoms last more than 7 days or condition worsens.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact Poison Center immediately.

Section 51727-6 (51727-6)

Water, Aloe Barbadensis Leaf Juice(1), Disodium Cocoyl Glutamate, Glyceryl Laurate, Glycerin, Glyceryl Stearate SE, Stearyl Alcohol, Cocos Nucifera (Coconut) Oil (1), Sodium Laurylglucosides Hydroxypropylsulfonate, Xanthan Gum, Linum Usatatissimum (Linseed) Seed Oil (1), Gluconolactone, Calcium Gluconate, Citric Acid, Sodium Chloride, Sodium Benzoate.

(1) Certified Organicf Ingredient

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Colloidal Oatmeal - 1.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:22.303167 · Updated: 2026-03-14T22:59:19.689823