INTENSIVE SKIN REPAIR
- Manufacturer
- PUREMEDY
- Effective date
- 2021-10-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:15:15
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS
SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)
ORG. CALENDULA (1X) HPUS (MARIGOLD)
PINUS LAMBERTIANA (1X) HPUS (PINE RESIN)
ABIES BALSAMEA (1X) HPUS (BALSAM FIR)
OTC - PURPOSE SECTION
PROPERTIES
ANTI-INFLAMMATORY
SKIN HEALING REMEDY
SKIN PROTECTANT
SKIN PROTECTANT
INDICATIONS & USAGE SECTION
USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH EXTREMELY DRY, DAMAGED, OR AGING SKIN.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS: APPLY TO AFFECTED AREA MORNING AND/OR NIGHT.
INACTIVE INGREDIENT SECTION
OTHER INGREDIENTS: ORGANIC BEESWAX, ORGANIC OLIVE OIL, ORGANIC ARGAN OIL, ORGANIC SEA BUCKTHORN OIL
WARNINGS SECTION
WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER. (* = CERTIFIED ORGANIC INGREDIENTS)
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN.
OTC - QUESTIONS SECTION
CUSTOMER SERVICE: 8:AM - 5:PM M - F 310-526-6108
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52810-204-11 | 2023-01-30 | C162847 | 48780-1 | 9855d018-d31c-cd31-e053-dbdaa90ab51a | INTENSIVE SKIN REPAIR (52810-204) |
| 52810-204-11 | 2020-06-02 | C162847 | 48780-1 | 9855d018-d31c-cd31-e053-dbdaa90ab51a | INTENSIVE SKIN REPAIR (52810-204) |
| 52810-204-11 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d31c-cd31-e053-dbdaa90ab51a | INTENSIVE SKIN REPAIR (52810-204) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52810-204-11 | INTENSIVE SKIN REPAIR | 30 mL in 1 JAR | SALVE | 30 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52810-204 | INTENSIVE SKIN REPAIR (SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINUS LAMBERTIANA RESIN ABIES BALSAMEA LEAF OIL) SALVE [PUREMEDY] | 3 | Legacy NDC, 1 package rows | 20211221_c25785a5-2f84-4e6f-8ae0-7a3d1b939485.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ABIES BALSAMEA LEAF OIL | ACTIVE INGREDIENT | 2FGT9T2SQC | 1 | |
| CALENDULA OFFICINALIS FLOWER | ACTIVE INGREDIENT | P0M7O4Y7YD | 1 | |
| PINUS LAMBERTIANA RESIN | ACTIVE INGREDIENT | 1D686UF007 | 1 | |
| SAMBUCUS NIGRA FLOWER | ACTIVE INGREDIENT | 07V4DX094T | 1 | |
| ABIES BALSAMEA LEAF OIL | ACTIVE MOIETY | 2FGT9T2SQC | 1 | |
| CALENDULA OFFICINALIS FLOWER | ACTIVE MOIETY | P0M7O4Y7YD | 1 | |
| PINUS LAMBERTIANA RESIN | ACTIVE MOIETY | 1D686UF007 | 1 | |
| SAMBUCUS NIGRA FLOWER | ACTIVE MOIETY | 07V4DX094T | 1 | |
| ARGAN OIL | INACTIVE INGREDIENT | 4V59G5UW9X | 1 | |
| HIPPOPHAE RHAMNOIDES WHOLE | INACTIVE INGREDIENT | YAA7TG74X6 | 1 | |
| OLIVE OIL | INACTIVE INGREDIENT | 6UYK2W1W1E | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- INTENSIVE SKIN REPAIR
- SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINUS LAMBERTIANA RESIN ABIES BALSAMEA LEAF OIL
- OLIVE OIL
- ARGAN OIL
- YELLOW WAX
- HIPPOPHAE RHAMNOIDES WHOLE
- SAMBUCUS NIGRA FLOWER
- CALENDULA OFFICINALIS FLOWER
- PINUS LAMBERTIANA RESIN
- ABIES BALSAMEA LEAF OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52810-204 | 52810-204-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OLIVE OIL | 6UYK2W1W1E | IACT |
| ARGAN OIL | 4V59G5UW9X | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| HIPPOPHAE RHAMNOIDES WHOLE | YAA7TG74X6 | IACT |
| SAMBUCUS NIGRA FLOWER | 07V4DX094T | ACTIB |
| CALENDULA OFFICINALIS FLOWER | P0M7O4Y7YD | ACTIB |
| PINUS LAMBERTIANA RESIN | 1D686UF007 | ACTIB |
| ABIES BALSAMEA LEAF OIL | 2FGT9T2SQC | ACTIB |
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 |
|---|---|---|---|---|---|---|
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOLUTION / ORAL | 425 mg/1ml | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOAP / TOPICAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | CAPSULE / ORAL | NA | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | LOTION / TOPICAL | 32468 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOLUTION / TOPICAL | 0.6 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %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 |
|---|---|---|---|---|---|---|
| cdb78d1e-0e23-7e5b-e053-2995a90abc43 | c25785a5-2f84-4e6f-8ae0-7a3d1b939485 | 2021-10-06 | Warnings | cdb78d1e-0e23-7e5b-e053-2995a90abc43 c25785a5-2f84-4e6f-8ae0-7a3d1b939485 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
