ZARAZYL- barrier cream cream 
Dara Craiceann Limited

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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For external use only.
For equine animal use only.
Store in cool dry conditions.
Keep out of reach of children.
Not for use in Horses intended for food.

Clean and dry affected area before use. Apply cream liberally once or twice daily.   

Package Label 08 Aug 2019.jpg

Package Label

ZARAZYL 
barrier cream cream
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86107-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9) (ORTHOSILICIC ACID - UNII:623B93YABH) ORTHOSILICIC ACID0.074 g  in 200 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
Colorwhite (white/off white cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86107-001-01200 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/12/2019
Labeler - Dara Craiceann Limited (985720091)
Establishment
NameAddressID/FEIBusiness Operations
Dara Craiceann Limited985720091label
Establishment
NameAddressID/FEIBusiness Operations
Ovelle Ltd.219542784api manufacture, manufacture

Revised: 11/2021
Document Id: 560bc36d-3ba5-4d6f-bad7-1a60ecc220cd
Set id: 612e899e-8743-4963-9eae-8a7489bc7c7d
Version: 2
Effective Time: 20211119
 
Dara Craiceann Limited