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#

ProductINTENSIVE SKIN REPAIR
Active ingredientSAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, PINUS LAMBERTIANA RESIN, ABIES BALSAMEA LEAF OIL
Label structure9 sections

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

intensive skin repairintensive skin repair

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52810-204-11INTENSIVE SKIN REPAIR30 mL in 1 JARSALVE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-204INTENSIVE SKIN REPAIR (SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINUS LAMBERTIANA RESIN ABIES BALSAMEA LEAF OIL) SALVE [PUREMEDY]3Legacy NDC, 1 package rows20211221_c25785a5-2f84-4e6f-8ae0-7a3d1b939485.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ABIES BALSAMEA LEAF OILACTIVE INGREDIENT2FGT9T2SQC1
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD1
PINUS LAMBERTIANA RESINACTIVE INGREDIENT1D686UF0071
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094T1
ABIES BALSAMEA LEAF OILACTIVE MOIETY2FGT9T2SQC1
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD1
PINUS LAMBERTIANA RESINACTIVE MOIETY1D686UF0071
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094T1
ARGAN OILINACTIVE INGREDIENT4V59G5UW9X1
HIPPOPHAE RHAMNOIDES WHOLEINACTIVE INGREDIENTYAA7TG74X61
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52810-20452810-204-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cdb78d1e-0e23-7e5b-e053-2995a90abc43c25785a5-2f84-4e6f-8ae0-7a3d1b9394852021-10-06WarningsExact identifier
spl id: cdb78d1e-0e23-7e5b-e053-2995a90abc43
spl set id: c25785a5-2f84-4e6f-8ae0-7a3d1b939485

Reported adverse events (FAERS/openFDA)#

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