FDA.reportPublic FDA data

PCA Skin Procedure Ointment

Manufacturer
Colgate Palmolive Skin Health Group, Inc.
Effective date
2025-04-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:39:57

Label at a glance#

ProductPCA Skin Skin Procedure
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

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

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

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

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 if

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

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

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.

Questions or comments?

OTC - QUESTIONS SECTION

877.722.7546

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OuterLabel.jpgOuterLabel.jpgInnerLabel.jpgInnerLabel.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-690PCA SKIN SKIN PROCEDURE (PETROLATUM) OINTMENT [COLGATE PALMOLIVE SKIN HEALTH GROUP, INC.]2Unmatched20250406_3fc13c65-be74-464b-9d99-a68c0a209b39.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-69068726-690-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL65UEH262ISIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
RICE BRANR60QEP13ICIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ROSEMARYIJ67X351P9IACT
MILK THISTLEU946SH95EEIACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PETROLATUM4T6H12BN9UACTIB

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
31f62a42-e391-8150-e063-6294a90a40a83fc13c65-be74-464b-9d99-a68c0a209b392025-04-04WarningsExact identifier
spl id: 31f62a42-e391-8150-e063-6294a90a40a8
spl set id: 3fc13c65-be74-464b-9d99-a68c0a209b39

Reported adverse events (FAERS/openFDA)#

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