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
Theraplex
- Manufacturer
- The Theraplex Company, LLC | Memphis Contract Packaging, Inc.
- Effective date
- 2015-10-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:43:55
Label at a glance#
ProductTheraplex HEALING EMOLLIENT
Active ingredientPETROLATUM
Label structure11 sections
Storage and handling
Other information • store at room temperature • keep from freezing
Contacts and useful links#
Websitewww.theraplex.com
www.theraplex.com
www.theraplex.comLabel contents#
Full prescribing information#
Active Ingredient
Petrolatum (65%)
Purpose
Skin Protectant
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.
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
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
DOSAGE & ADMINISTRATION SECTION
Directions apply as needed, or as directed by your doctor.
INACTIVE INGREDIENT SECTION
Inactive Ingredients cyclomethicone, microcrystalline wax
STORAGE AND HANDLING SECTION
Other information • store at room temperature • keep from freezing
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
Net Wt. 8oz. (226.7g)
Distributed by:
The Theraplex Company, LLC
Memphis, TN 38119
Packaging
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62917-065-08 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-15c0-fd44-e053-dadaa90aa01b | theraplex HEALING EMOLLIENT |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62917-065-08 | TheraplexHEALING EMOLLIENT | 226.7 g in 1 JAR | CREAM | 226.7 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PETROLATUM | ACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PETROLATUM | ACTIVE MOIETY | 4T6H12BN9U | 1 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 |
Products#
Every source-derived product name is available through these pages.
- Theraplex HEALING EMOLLIENT
- PETROLATUM
- CYCLOMETHICONE
- MICROCRYSTALLINE WAX
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62917-065 | 62917-065-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PETROLATUM | 4T6H12BN9U | ACTIB |
| CYCLOMETHICONE | NMQ347994Z | IACT |
| MICROCRYSTALLINE WAX | XOF597Q3KY | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CREAM / VAGINAL | 23 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | GEL / TOPICAL | NA | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | OINTMENT / TOPICAL | 3575 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CAPSULE, EXTENDED RELEASE / ORAL | 6 mg | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | SOLUTION / TOPICAL | 11.57 %w/v | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | AEROSOL, FOAM / TOPICAL | 5.26 %w/w | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | CREAM / TOPICAL | 13 %w/w | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | LOTION / TOPICAL | 3510 mg | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | CREAM, AUGMENTED / TOPICAL | 7.6 %w/w |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 91199a78-e92e-487e-8417-f0c5ee60d6d2 | e76e2f90-8c10-4354-8dfe-b4358018645c | 2015-10-23 | Warnings | 91199a78-e92e-487e-8417-f0c5ee60d6d2 e76e2f90-8c10-4354-8dfe-b4358018645c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.