ZARASYL COMPANION- 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 animal use only.

Store in cool dry conditions.

Keep out of reach of children.

Not for use in animals intended for food.
Do not use on deep or puncture wounds

Discontinue use and consult your veterinarian if swelling, redness, irritation or excessive drainage develops at the site of application or if healing is delayed

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

image description

ZARASYL COMPANION
barrier cream cream

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:86107-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDRATED SILICA (UNII: Y6O7T4G8P9) (ORTHOSILICIC ACID - UNII:623B93YABH)	ORTHOSILICIC ACID	0.074 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white (white/off white cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:86107-002-01	50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/27/2022

Labeler - Dara Craiceann Limited (985720091)

Name	Address	ID/FEI	Business Operations
Establishment
Dara Craiceann Limited		985720091	label

Name	Address	ID/FEI	Business Operations
Establishment
Ovelle Ltd.		219542784	manufacture, api manufacture