Barrier Protectant Cream

Manufacturer
Cardinal Health
Effective date
2025-08-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:11:22

Label at a glance#

ProductBarrier Protectant Cream
Active ingredientMENTHOL, ZINC OXIDE
Label structure9 sections

Indications and uses

A moisture barrier that provides temporary relief from skin irritations caused by   •urine   •diarrhea   •perspiration   •fistula drainage   •feeding tube site leakage   •wound drainage (peri-wound skin)   •minor burns   •cuts   •scrapes   •anorectal itching   •chafing Dries the oozing and weeping of poison   •ivy   •oak   •sumac

Dosage and administration

Gently cleanse and remove any urine or fecal matter from the treatment area Pat dry Apply a generous amount of product to the affected area Repeat after every incontinent episode or as needed For peri-G tubes: •Cleanse as above  •Apply thin layer  •Secure with drain sponge or product as directed.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

  • Menthol 0.1%
  • Zinc oxide 20%

Purpose

OTC - PURPOSE SECTION

  • Anorectal analgesic
  • Skin protectant

Uses

INDICATIONS & USAGE SECTION

A moisture barrier that provides temporary relief from skin irritations caused by   •urine   •diarrhea   •perspiration   •fistula drainage   •feeding tube site leakage   •wound drainage (peri-wound skin)   •minor burns   •cuts   •scrapes   •anorectal itching   •chafing

Dries the oozing and weeping of poison   •ivy   •oak   •sumac

Warnings

WARNINGS SECTION

For external use only.

  • Avoid contact with the eyes
  • Stop use and contact a physician if condition 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
  • Serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Gently cleanse and remove any urine or fecal matter from the treatment area
  • Pat dry
  • Apply a generous amount of product to the affected area
  • Repeat after every incontinent episode or as needed
  • For peri-G tubes: •Cleanse as above  •Apply thin layer  •Secure with drain sponge or product as directed.

Other information

OTHER SAFETY INFORMATION

Store between 59°-86°F (15°-30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Active aloe gel, Calamine, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Glycerin, Lanolin, Light mineral oil, Manuka honey, Methylparaben, Microcrystalline wax, Petrolatum, Propylparaben, Sodium borate, Sorbitan oleate, Tocopherol, Water

Barrier Protectant Cream Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label (2 oz)

Cardinal 2oz TubeCardinal 2oz Tube

Tube Label (4 oz)

Cardinal 4oz TubeCardinal 4oz Tube

Packet Labels (Box of 150)

Cardinal PacketsCardinal Packets

Cardinal Packet BoxCardinal Packet Box

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63517-003-31Barrier Protectant Cream113 g in 1 TUBEOINTMENT1134
63517-003-32Barrier Protectant Cream57 g in 1 TUBEOINTMENT574
63517-003-34Barrier Protectant Cream5 g in 1 POUCHOINTMENT54
63517-003-34Barrier Protectant Cream150 in 1 BOXOINTMENT1504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
MENTHOLACTIVE MOIETYL7T10EIP3A1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
COD LIVER OILINACTIVE INGREDIENTBBL281NWFG1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HONEYINACTIVE INGREDIENTY9H1V576FH1
LANOLININACTIVE INGREDIENT7EV65EAW6H1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD561
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63517-00363517-003-31, 63517-003-32, 63517-003-34
51028-002

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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 2 · 65 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOCREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOCREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOCREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOCREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOCREAM / TOPICALNAExact identifier — unii+route
5 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route
10 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Barrier Protectant CreamBARRIER CREAMCardinal Health539d9aac-75cf-4efd-bb3e-b465563304ca2025-08-21WarningsExact identifier
ndc (package): 63517-003-32
ndc (package): 63517-003-34
ndc (package): 63517-003-31
ndc (product): 63517-003
ndc11 (package): 63517000331
ndc11 (package): 63517000334
ndc11 (package): 63517000332
spl id: 3ce34f81-6708-c228-e063-6394a90a59d3
spl set id: 539d9aac-75cf-4efd-bb3e-b465563304ca
ChamosynBARRIER CREAMLinks Medical Productsf9dfb2d7-4684-4525-994e-1e0ff90413d92025-05-08WarningsExact identifier
ndc (product): 51028-002

Reported adverse events (FAERS/openFDA)#

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