Theraplex

Manufacturer: The Theraplex Company, LLC | Memphis Contract Packaging, Inc.
Effective date: 2018-02-22
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 22:54:41

Label at a glance#

ProductTheraplex Eczema Therapy Moisturizing skin protectant

Active ingredientOATMEAL

Label structure11 sections

Indications and uses

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

Dosage and administration

apply as needed, or as directed by your doctor.

Storage and handling

• store at room temperature • keep from freezing

Contacts and useful links#

PhoneLabel contact1-888-437-2753

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed, or as directed by your doctor.

Other information

STORAGE AND HANDLING SECTION

• store at room temperature • keep from freezing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cyclomethicone,microcrystalline wax, petrolatum(special fraction)

Questions?

OTC - QUESTIONS SECTION

call 1-888-437-2753

SPL UNCLASSIFIED SECTION

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
240464	colloidal oatmeal 1 % Topical Lotion	PSN	5
1492753	theraplex Eczema Therapy 1 % Topical Lotion	PSN	5
1492753	colloidal oatmeal 10 MG/ML Topical Lotion [Theraplex Eczema Therapy]	SBD	5
240464	colloidal oatmeal 10 MG/ML Topical Lotion	SCD	5
240464	colloidal oatmeal 1 % Topical Lotion	SY	5
1492753	Theraplex Eczema Therapy 1 % Topical Lotion	SY	5
1492753	Theraplex Eczema Therapy 10 MG/ML Topical Lotion	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OATMEAL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62917-350-01	2021-07-23	C162847	48780-1	c7ccaba7-20ca-fd44-e053-dadaa90aa01b	Theraplex
62917-350-06	2021-07-23	C162847	48780-1	c7ccaba7-20ca-fd44-e053-dadaa90aa01b	Theraplex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62917-350-01	Theraplex Eczema Therapy Moisturizing skin protectant	128 g in 1 TUBE	LOTION	128		5
62917-350-06	Theraplex Eczema Therapy Moisturizing skin protectant	170.1 g in 1 JAR	LOTION	170.1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62917-350	THERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT (COLLOIDAL OATMEAL) LOTION [THE THERAPLEX COMPANY, LLC]	5	Legacy NDC, 2 package rows	20180222_47b50665-1909-411f-b6e0-d24602811c99.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	3
OATMEAL	ACTIVE MOIETY	8PI54V663Y	3
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	3
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Theraplex Eczema Therapy Moisturizing skin protectant
Colloidal Oatmeal
OATMEAL
CYCLOMETHICONE
MICROCRYSTALLINE WAX
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62917-350	62917-350-01, 62917-350-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OATMEAL	8PI54V663Y	ACTIB
CYCLOMETHICONE	NMQ347994Z	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
PETROLATUM	4T6H12BN9U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	CREAM / VAGINAL		23 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	CAPSULE, EXTENDED RELEASE / ORAL	6 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	LOTION / TOPICAL		3510 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	SOLUTION / TOPICAL	11.57 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	OINTMENT / TOPICAL		3575 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	CREAM, AUGMENTED / TOPICAL	7.6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	AEROSOL, FOAM / TOPICAL	5.26 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	CREAM / TOPICAL	13 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9d6e2374-7834-46e5-a368-2f5918706ebf			47b50665-1909-411f-b6e0-d24602811c99	2018-02-22	Warnings	Exact identifier spl id: 9d6e2374-7834-46e5-a368-2f5918706ebf spl set id: 47b50665-1909-411f-b6e0-d24602811c99

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.