BARRIER PROTECTANT CREAM- barrier cream ointment 
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Barrier Protectant Cream

Active ingredients

Purpose

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

Warnings

For external use only.

Do not use:

Keep out of reach of children.

Directions

Other information

Store between 59°-86°F (15°-30°C)

Inactive Ingredients

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

Tube Label (2 oz)

Cardinal 2oz Tube

Tube Label (4 oz)

Cardinal 4oz Tube

Packet Labels (Box of 150)

Cardinal Packets

Cardinal Packet Box

BARRIER PROTECTANT CREAM 
barrier cream ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-003(NDC:51028-002)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CHAMOMILE (UNII: FGL3685T2X)  
COD LIVER OIL (UNII: BBL281NWFG)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
HONEY (UNII: Y9H1V576FH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63517-003-31113 g in 1 TUBE; Type 0: Not a Combination Product01/15/2015
2NDC:63517-003-3257 g in 1 TUBE; Type 0: Not a Combination Product01/15/2015
3NDC:63517-003-34150 in 1 BOX01/15/2015
35 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/15/2015
Labeler - Cardinal Health (961027315)

Revised: 1/2020
Document Id: 9d14b560-aeae-535e-e053-2a95a90a1e04
Set id: 539d9aac-75cf-4efd-bb3e-b465563304ca
Version: 3
Effective Time: 20200126
 
Cardinal Health