FDA.reportPublic FDA data

Zarazyl

Manufacturer
Dara Craiceann Limited | Ovelle
Effective date
2024-10-21
Label type
OTC ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:43:40

Label at a glance#

ProductZarasyl
Active ingredientHYDRATED SILICA
Label structure3 sections

Label contents#

Full prescribing information#

PRECAUTIONS SECTION

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.

INSTRUCTIONS FOR USE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label 08 Aug 2019.jpg

Package LabelPackage Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86107-001-01Zarasyl200 mL in 1 TUBECREAM2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86107-001ZARASYL (BARRIER CREAM) CREAM [DARA CRAICEANN LIMITED]41 package rows20241023_612e899e-8743-4963-9eae-8a7489bc7c7d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86107-00186107-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDRATED SILICAY6O7T4G8P9ACTIM
Water059QF0KO0RIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.