SHIELD AND PROTECT BARRIER CREAM- petroleum, zinc oxide cream

Shield and Protect Barrier Cream by

Drug Labeling and Warnings

Shield and Protect Barrier Cream by is a Otc medication manufactured, distributed, or labeled by gentell inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide

Petrolatum

Keep out of rach of children

Keep out of reach of Children

Inactive Ingredients

Purified water

Mineral oil

Sodium Chloride

Castor wax

Bees wax

Imidazolidinyl Urea

Propylparaben

Methylparaben

Vitamin A Palmitate

Cetostearyl alcohol

Vitamin D 3

Purpose

Gentell Shield & Protect Moisture Barrier Cream forms a water-shedding shield thta helps soothe and protect dry or irritated skin. Theraprutic against irritation from urine, feces, and other bodily secretions. Sheild & Protect leaves skin soft and smooth rather than irretated and greasy. Ideal for sensitive skin.

Warnings

For external use only

Avoid eye contact

Discontinue use and contact a physiciean if condition worsens, or symptoms persist from more than seven days

Keep this out of the reah of children

Dosage & Administration

Carefully cleanse the area and pat dry thoroughly. Apply liberally to desired areas as often as necessary or when prolonged wxposure is anticipated.

Indication and usage

Shield & Protect Moisture Barrier Cream helps restore, replenish and soothe ry irritated or otherwise compromised skin.

It helps treat or pevent minor skin irritations assoiated with incontinence.

Protects fom and seals out wetness

Primary Label

INGREDIENTS AND APPEARANCE

SHIELD AND PROTECT BARRIER CREAM 
petroleum, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61554-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.13 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	10.32 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)	20.64 g  in 100 g
CHOLECALCIFEROL (UNII: 1C6V77QF41)	0.05 g  in 100 g
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)	0.03 g  in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.48 g  in 100 g
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)	0.36 g  in 100 g
WATER (UNII: 059QF0KO0R)	59.52 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.1 g  in 100 g
IMIDUREA (UNII: M629807ATL)	0.3 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.25 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	3.44 g  in 100 g
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)	0.36 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61554-500-01	118 g in 1 TUBE; Type 0: Not a Combination Product	11/13/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/13/2014

Labeler - gentell inc (170967876)

Establishment
Name	Address	ID/FEI	Business Operations
gentell inc		170967876	manufacture(61554-500)