Theraplex 

Theraplex 
SPL v5
SPL
SPL Set ID 47b50665-1909-411f-b6e0-d24602811c99
Route
TOPICAL
Published
Effective Date 2018-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1 g)
Inactive Ingredients
Cyclomethicone Microcrystalline Wax Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Completed Since 2013-11-01 Until 2020-07-01
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

Section 42229-5

Does not contain antibiotics.

Not tested on animals.

Distributed by:

The Theraplex Company, LLC

Memphis,TN 38119

Steroid Free

Fragrance Free

Paraben Free

Preservative Free

Gluten Free

Noncomedogenic

Hypoallergenic

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

When using this product  do not get into eyes.

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.

Packaging

Directions

apply as needed, or as directed by your doctor.

Drug Facts

Questions?

call 1-888-437-2753

Other Information

• store at room temperature  • keep from freezing

Active Ingredients

Colloidal Oatmeal 1% 

Inactive Ingredients

cyclomethicone,microcrystalline wax, petrolatum(special fraction)

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Does not contain antibiotics.

Not tested on animals.

Distributed by:

The Theraplex Company, LLC

Memphis,TN 38119

Steroid Free

Fragrance Free

Paraben Free

Preservative Free

Gluten Free

Noncomedogenic

Hypoallergenic

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Skin Protectant

Warnings

For external use only.

When using this product  do not get into eyes.

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.

Packaging

Directions

apply as needed, or as directed by your doctor.

Drug Facts

Questions?

call 1-888-437-2753

Other Information (Other information)

• store at room temperature  • keep from freezing

Active Ingredients

Colloidal Oatmeal 1% 

Inactive Ingredients

cyclomethicone,microcrystalline wax, petrolatum(special fraction)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:31.514387 · Updated: 2026-03-14T22:55:03.293878