Zarazyl: Product Information

ZARAZYL- 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 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
(click image for full-size original)
ZARAZYL
barrier cream cream
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86107-001
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 200 mL
Inactive Ingredients
Ingredient Name Strength
Water
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
PHENOXYETHANOL
SODIUM CHLORIDE
Product Characteristics
Color white (white/off white cream) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86107-001-01 200 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/12/2019
Labeler — Dara Craiceann Limited (985720091)
Establishment
Name Address ID/FEI Operations
Dara Craiceann Limited 985720091 label
Establishment
Name Address ID/FEI Operations
Europharma Concepts 896333478 api manufacture, manufacture

Revised: 08/2019 Dara Craiceann Limited

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