Label at a glance#

ProductTheraplex Healing Emollient

Active ingredientPETROLATUM

Label structure11 sections

Indications and uses

• temporarily protects and helps relieve chapped or cracked skin and lips • helps protect from the drying effects of wind and cold weather • temporarily protects minor: • cuts • scrapes • burns

Storage and handling

Other information • store at room temperature • keep from freezing

Contacts and useful links#

PhoneLabel contact1-888-437-2753

Websitewww.theraplex.com

www.theraplex.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum (65%)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

• temporarily protects and helps relieve chapped or cracked skin and lips • helps protect from the drying effects of wind and cold weather • temporarily protects minor: • cuts • scrapes • burns

WARNINGS SECTION

Warnings For external use only

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

Do not use on • deep or puncture wounds • animal bites • serious burns

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.

DOSAGE & ADMINISTRATION SECTION

Directions apply as needed, or as directed by your doctor.

STORAGE AND HANDLING SECTION

Other information • store at room temperature • keep from freezing

INACTIVE INGREDIENT SECTION

Inactive Ingredients cyclomethicone, microcrystalline wax

OTC - QUESTIONS SECTION

Questions? call 1-888-437-2753

SPL UNCLASSIFIED SECTION

Clinically-proven Theraplex Healing Emollient combines a unique enriched special petrolatum fraction (ESPF) with a novel hydrosilicone delivery system that deeply penetrates severely dry skin. Dermatologists have recommended this healing formulation for years because of its ability to deliver soothing moisturization and long-lasting skin barrier protection with no irritation to sensitive, compromised skin.

Noncomedogenic (Won't Clog Pores)
Hypoallergenic
Preservative-Free
Fragrance-Free
Paraben-Free
Gluten-Free

Skin Protectant • For Severely Dry & Sensitive Skin
Dermatologist recommended for adults & children

Distributed by:
The Theraplex Company, LLC
Memphis, TN 38119
www.theraplex.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healing Emollient

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1716270	petrolatum 65 % Topical Cream	PSN	1
1716270	petrolatum 650 MG/ML Topical Cream	SCD	1
1716270	petrolatum 65 % Topical Cream	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62917-065-02	2021-07-23	C162847	48780-1	c7ccaba7-1932-fd44-e053-dadaa90aa01b	Theraplex Healing Emollient

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62917-065-02	TheraplexHealing Emollient	56.6 g in 1 JAR	CREAM	56.6		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62917-065	THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]	1	Legacy NDC, 1 package rows	20170501_1af2e6c9-aa62-43a3-9eaf-342fe1bdd598.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Theraplex Healing Emollient
Petrolatum
CYCLOMETHICONE
MICROCRYSTALLINE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62917-065	62917-065-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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

Source Document#

Source XML

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
bfa9931f-9f45-4c95-87f5-65ed93d295f5			1af2e6c9-aa62-43a3-9eaf-342fe1bdd598	2017-02-16	Warnings	Exact identifier spl id: bfa9931f-9f45-4c95-87f5-65ed93d295f5 spl set id: 1af2e6c9-aa62-43a3-9eaf-342fe1bdd598

Reported adverse events (FAERS/openFDA)#

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