BARRIER PROTECTANT CREAM- barrier cream ointment 
Bershtel Enterprises

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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MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g

Purpose

Anorectal analgesic
Skin protectant

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.

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

Keep out of reach of children.

Directions

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.

Store between 59°-86°F (15°-30°C)

Inactive Ingredients
Ingredient Name Strength
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)

Consumer BoxPacket

BARRIER PROTECTANT CREAM 
barrier cream ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10564-0033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.5 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)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
LANOLIN (UNII: 7EV65EAW6H)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
HONEY (UNII: Y9H1V576FH)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10564-0033-41 in 1 BOX01/15/2015
1NDC:10564-0033-05 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 - Bershtel Enterprises (066659129)

Revised: 1/2018
 
Bershtel Enterprises