Theraplex Eczema Therapy

SPL v1

SPL

SPL Set ID 86472a3d-7138-4141-8422-ab20c17a46e0

Route

TOPICAL

Published

Effective Date 2023-12-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Oatmeal (10 mg)

Inactive Ingredients

Cyclomethicone Ceresin Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-12-19

Description

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Colloidal Oatmeal 1%

Uses

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

Warnings

For external use only

Directions

apply as needed, or as directed by your doctor.

Questions?

email [email protected]

Active Ingredient

Colloidal Oatmeal 1%

Other Information

store at room temperature
keep from freezing

Package Labeling:

Inactive Ingredients

cyclomethicone, ozokerite wax, petrolatum (special fraction)

When Using This Product

do not get into eyes.

Stop and Ask A Doctor If

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

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

Purpose

Skin Protectant

Warnings

For external use only

Directions

apply as needed, or as directed by your doctor.

Questions?

email [email protected]

Active Ingredient

Colloidal Oatmeal 1%

Other Information (Other information)

store at room temperature
keep from freezing

Package Labeling:

Inactive Ingredients

cyclomethicone, ozokerite wax, petrolatum (special fraction)

When Using This Product (When using this product)

do not get into eyes.

Stop and Ask A Doctor If (Stop and ask a doctor if)

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "CYCLOMETHICONE", "unii": "NMQ347994Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OATMEAL", "unii": "8PI54V663Y", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily protects and helps relieve minor skin irritation and itching due to: • eczema • rashes", "Purpose": "Skin Protectant", "Warnings": "For external use only", "Directions": "apply as needed, or as directed by your doctor.", "Questions?": "email help@theraplex.com", "Active Ingredient": "Colloidal Oatmeal 1%", "Other information": "store at room temperature keep from freezing", "Inactive Ingredients": "cyclomethicone, ozokerite wax, petrolatum (special fraction)", "When using this product": "do not get into eyes.", "Stop and ask a doctor if": "condition worsens symptoms last more than 7 days or clear up and occur again within a few days", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.993816 · Updated: 2026-03-14T23:02:09.430554