DR527

Manufacturer
Physicians Care Alliance, LLC dba PCA Skin
Effective date
2021-10-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:42:38

Label at a glance#

ProductDR527
Active ingredientPETROLATUM
Label structure15 sections

Indications and uses

Helps relieve, prevent and temporarily protect chafed, chapped or cracked skin. Use as a lubricant to prevent further irritation.

Dosage and administration

Apply as needed or as directed by physician for best results, apply liberally to moist skin

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum (60%)

Purpose

OTC - PURPOSE SECTION

Skin protectant (ointment)

Uses

OTC - PURPOSE SECTION

Helps relieve, prevent and temporarily protect chafed, chapped or cracked skin. Use as a lubricant to prevent further irritation.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor it

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Do not use

OTC - DO NOT USE SECTION

on damaged and broken skin

Directions

INSTRUCTIONS FOR USE SECTION

  • Apply as needed or as directed by physician
  • for best results, apply liberally to moist skin

Other Information

OTHER SAFETY INFORMATION

  • Do not use if package is broken or open
  • protect this product from excessive heat and direct sun
  • noncomedogic
  • fragrance-free
  • hypoallergenic

Questions?

OTC - QUESTIONS SECTION

Please call 877.722.7546

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed or as directed by physician
  • for best results, apply liberally to moist skin

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Panthenol, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silybum Marianum Fruit Extract, Stearyl Glycyrrhetinate, Tocopherol, Tocopheryl Acetate.

Uses

INDICATIONS & USAGE SECTION

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCA 7oz Skin OintmentPCA 7oz Skin Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2467180petrolatum 60 % Topical OintmentPSN5
2467180petrolatum 0.6 MG/MG Topical OintmentSCD5
2467180petrolatum 60 % Topical OintmentSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68726-527-012023-01-30C16284748780-1f386c64a-0d51-0266-e053-dadaa90a7c1aaaadb6ae-a3a2-ed2e-e053-2995a90a1abd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68726-527-01DR527207 mL in 1 TUBEOINTMENT2075

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-527DR527 (SKIN PROCEDURE OINTMENT) OINTMENT [PHYSICIANS CARE ALLIANCE, LLC DBA PCA SKIN]5Legacy NDC, 1 package rows20211007_aaadb6ae-a3a2-ed2e-e053-2995a90a1abd.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-52768726-527-01

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
NameUNIIKind
SAFFLOWER OIL65UEH262ISIACT
PETROLATUM4T6H12BN9UACTIB
PANTHENOLWV9CM0O67ZIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cdb28639-0451-5bbd-e053-2995a90a4c54aaadb6ae-a3a2-ed2e-e053-2995a90a1abd2021-10-06WarningsExact identifier
spl id: cdb28639-0451-5bbd-e053-2995a90a4c54
spl set id: aaadb6ae-a3a2-ed2e-e053-2995a90a1abd

Reported adverse events (FAERS/openFDA)#

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