FDA.reportPublic FDA data

Cardinal Barrier Ointment

Manufacturer
Cardinal Health
Effective date
2020-11-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:52:51

Label at a glance#

ProductBarrier Skin Protectant
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

For the temporary protection of: diaper rash, minor cuts, scrapes and burns Temporarily protects and helps relieve chapped or cracked skin Helps protect from the drying effects of wind and cold weather

Dosage and administration

Gently cleanse and remove any urine or fecal matter from treatment area Pat dry Apply generous amount of product to the affected area Repeat after every incontinent episode or as needed To use as a moisturizer, apply liberally and massage into skin

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

  • For external use only
  • Avoid contact with the eyes
  • Stop use and contact a physician if conditions worsens, symptoms last more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children
  • If swallowed, get medical help or contact Poison Control Center right away
  • Do not use on deep or puncture wounds, animal bites or serious burns

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 43%      Skin Protectant

Uses

OTC - PURPOSE SECTION

  • For the temporary protection of: diaper rash, minor cuts, scrapes and burns
  • Temporarily protects and helps relieve chapped or cracked skin
  • Helps protect from the drying effects of wind and cold weather

Directions

DOSAGE & ADMINISTRATION SECTION

  • Gently cleanse and remove any urine or fecal matter from treatment area
  • Pat dry
  • Apply generous amount of product to the affected area
  • Repeat after every incontinent episode or as needed
  • To use as a moisturizer, apply liberally and massage into skin

Other Information

OTHER SAFETY INFORMATION

Store between 15-30oC (59-86oF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, hydroxlated lanolin, PEG-30 dipolyhydroxystearate, sorbitan sesquioleate, mineral oil, glycerin, steareth-20, ozokerite wax, magnesium sulfate, aloe barbadensis leaf juice, DMDM hydantoin, iodopropynyl butylcarbamate

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Barrier Ointment Artwork.jpgBarrier Ointment Artwork.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63517-021-022021-02-12C16284748780-1ba0f9c33-383a-a910-e053-dadaa90a0b85Cardinal Barrier Ointment
63517-021-042021-02-12C16284748780-1ba0f9c33-383a-a910-e053-dadaa90a0b85Cardinal Barrier Ointment
63517-021-052021-02-12C16284748780-1ba0f9c33-383a-a910-e053-dadaa90a0b85Cardinal Barrier Ointment

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
63517-02163517-021-02, 63517-021-04, 63517-021-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT
STEARETH-20L0Q8IK9E08IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
HYDROXYLATED LANOLINEOI0B9800CIACT
CERESINQ1LS2UJO3AIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT

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
54481e88-b8c8-4ddc-b82a-8cac3384991f5e6e6d22-611f-4b83-b0f2-c2bd2467b3182022-11-14WarningsExact identifier
spl set id: 5e6e6d22-611f-4b83-b0f2-c2bd2467b318

Reported adverse events (FAERS/openFDA)#

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