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

Purpose

Skin Protectant

Description

Colloidal Oatmeal 1%

Medication Information

Warnings

For external use only

Uses

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

Purpose

Skin Protectant

Directions

apply as needed, or as directed by your doctor.

Other Information

store at room temperature
keep from freezing

Inactive Ingredients

cyclomethicone, ozokerite wax, petrolatum (special fraction)

Description

Colloidal Oatmeal 1%

Questions?

email [email protected]

Active Ingredient

Colloidal Oatmeal 1%

Package Labeling:

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

Warnings

For external use only

Uses

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

Purpose

Skin Protectant

Directions

apply as needed, or as directed by your doctor.

Other Information (Other information)

store at room temperature
keep from freezing

Inactive Ingredients

cyclomethicone, ozokerite wax, petrolatum (special fraction)

Questions?

email [email protected]

Active Ingredient

Colloidal Oatmeal 1%

Package Labeling:

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