BARRIER PROTECTANT CREAM- barrier cream ointment

Barrier Protectant Cream by

Drug Labeling and Warnings

Barrier Protectant Cream by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

• Menthol 0.1%
• Zinc oxide 20%

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

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.

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)

Tube Label (4 oz)

Packet Labels (Box of 150)

INGREDIENTS AND APPEARANCE

BARRIER PROTECTANT CREAM 
barrier cream ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-003(NDC:51028-002)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-003-31	113 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2015
2	NDC: 63517-003-32	57 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2015
3	NDC: 63517-003-34	150 in 1 BOX	01/15/2015
3		5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/15/2015

Labeler - Cardinal Health (961027315)