SHIELD AND PROTECT BARRIER CREAM- petroleum, zinc oxide cream 
gentell inc

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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Sheild and Protect Barrier Cream

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

4oz Tube

SHIELD AND PROTECT BARRIER CREAM 
petroleum, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61554-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.13 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM10.32 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61554-500-01118 g in 1 TUBE; Type 0: Not a Combination Product11/13/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/13/2014
Labeler - gentell inc (170967876)
Establishment
NameAddressID/FEIBusiness Operations
gentell inc170967876manufacture(61554-500)

Revised: 5/2021
Document Id: c36a64da-226e-10a7-e053-2995a90acde4
Set id: b55810f7-2c21-1941-e053-2995a90a3cd5
Version: 2
Effective Time: 20210528
 
gentell inc