Active Ingredients
Colloidal oatmeal 1%
Renew Intensive Skin Therapy
- Manufacturer
- Melaleuca Inc.
- Effective date
- 2025-10-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:41:40
Label at a glance#
ProductRenew Intensive Skin Therapy Targeted Eczema Treatment
Active ingredientOATMEAL
Label structure11 sections
Label contents#
Full prescribing information#
Purpose
Skin protectant
INDICATIONS & USAGE SECTION
Uses Temporarily protects and helps relieve minor skin irritation and itching due to:
- rashes
- eczema
Warnings
For external use only
OTC - WHEN USING SECTION
When using this product avoid contact with eyes
OTC - STOP USE SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- apply as needed or as directed by a doctor
- for children under 2 years of age: ask a doctor
OTHER SAFETY INFORMATION
Other information
- for mild to moderate eczema
- store below 86 F (30 C)
INACTIVE INGREDIENT SECTION
water, glycerin, petrolatum, distearyldimonium chloride, isopropyl palmitate, cetyl alcohol, allantoin, benzyl alcohol, citric acid
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| OATMEAL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20181113 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54473-410-01 | Renew Intensive Skin TherapyTargeted Eczema Treatment | 50 mL in 1 TUBE, WITH APPLICATOR | CREAM | 50 | 3 |
Products#
Every source-derived product name is available through these pages.
- Renew Intensive Skin Therapy Targeted Eczema Treatment
- Colloidal Oatmeal
- PETROLATUM
- ISOPROPYL PALMITATE
- ALLANTOIN
- DISTEARYLDIMONIUM CHLORIDE
- OATMEAL
- GLYCERIN
- CETYL ALCOHOL
- WATER
- BENZYL ALCOHOL
- CITRIC ACID MONOHYDRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54473-410 | 54473-410-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PETROLATUM | 4T6H12BN9U | IACT |
| ISOPROPYL PALMITATE | 8CRQ2TH63M | IACT |
| ALLANTOIN | 344S277G0Z | IACT |
| DISTEARYLDIMONIUM CHLORIDE | OM9573ZX3X | IACT |
| OATMEAL | 8PI54V663Y | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2024-05-29 | full-release | 2026-06-01 00:13:04 |
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 |
|---|---|---|---|---|---|---|
| Renew Intensive Skin Therapy Targeted Eczema Treatment | COLLOIDAL OATMEAL | Melaleuca Inc. | 198c7caf-576b-1466-e063-6394a90afe25 | 2025-10-31 | Warnings | 54473-410-01 54473-410 54473041001 42790fbf-5c8b-ad6b-e063-6294a90af297 198c7caf-576b-1466-e063-6394a90afe25 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.