Zarasyl Companion: Product Information

ZARASYL COMPANION- hydrated silica 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.

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.

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ZARASYL COMPANION
barrier cream cream
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86107-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDRATED SILICA (ORTHOSILICIC ACID) ORTHOSILICIC ACID 0.074 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
Water
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
SODIUM CHLORIDE
PHENOXYETHANOL
Product Characteristics
Color white (white/off white cream) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86107-002-01 50 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/27/2022
Labeler — Dara Craiceann Limited (985720091)
Establishment
Name Address ID/FEI Operations
Dara Craiceann Limited 985720091 label
Establishment
Name Address ID/FEI Operations
Ovelle Ltd. 219542784 manufacture, api manufacture

Revised: 07/2022 Dara Craiceann Limited

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