FDA.reportPublic FDA data

EquiShield IR SPRAY

Manufacturer
Creative Science
Effective date
2025-12-29
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:45:41

Label at a glance#

ProductEquiShield IR
Active ingredientPRAMOXINE, HYDROCORTISONE
Label structure2 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 53413-015-08

Drug Facts:Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Pramoxine Hydrochloride .....1% (w/v)
Hydrocortisone .................. 1% (w/v)

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Anti-Inflammatory

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Propylene Glycol, Ethanol SDA-40, Octoxynol-10, Lanolin, Fragrance, Benzyl Alcohol, Safflower Oil, Oatmeal Extract.

Uses:

INDICATIONS & USAGE SECTION

EquiShield® IR (Itch Relief) Spray is a soothing anti-inflammatory formulation that contains Pramoxine and micronized colloidal oatmeal, combined with Hydrocortisone for the temporary relief of itching, flaking and inflammation. The EquiShield® IR Spray formulation starts with a moistening base for a long-lasting soothing effect. Added coat conditioners and Omega-6 Essential Fatty Acids nourish the skin and help control irritation. For use on horses, dogs and cats.

Cautions:

WARNINGS SECTION

For topical use on animals only. If redness or irritation persists or increases, discontinue use and consult your veterinarian. Avoid contact with eyes or open wounds. If contact with eyes occurs, flush thoroughly with water and consult a veterinarian.

Directions:

DOSAGE & ADMINISTRATION SECTION

SHAKE WELL BEFORE USE. Spray directly onto the affected skin area(s). If necessary, part the hair to ensure direct contact with the skin. Rub in well. May be used daily or as directed by veterinarian.

Other Information:

STORAGE AND HANDLING SECTION

• Store at room temperature 15° - 30° C (58° - 86° F).
• Store in a cool, dry place.

SPL UNCLASSIFIED SECTION

REV1025 #9008-03-00 UPC 851559000900

Manufactured for Creative Science

1700 Albany Place SE

Orange City, IA 51041

Phone: 888-506-3039

creative.science

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EquiShield IR Spray 8 ozEquiShield IR Spray 8 oz

EquiShield®

IR

SPRAY

Pramoxine 1%

Hydrocortisone 1%

with Colloidal Oatmeal

Itch Relief Spray

FOR VETERINARY USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

Net Contents: 8 fl oz. (236 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1541084hydrocortisone 1 % / pramoxine HCl 1 % Topical SprayPSN1
1541084hydrocortisone 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD1
1541084hydrocortisone 1 % / pramoxine HCl 1 % Topical SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130851559000900GTIN-13: 0851559000900
EAN-13: 0851559000900
GTIN-12: 851559000900
UPC-A: 851559000900
GTIN storage (14 digits): 00851559000900		EquiShield IR Spray 8 oz.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53413-015-08EquiShield IR236 mL in 1 BOTTLE, SPRAYSPRAY2361

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53413-01553413-015-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE068X84E056ACTIB
HYDROCORTISONEWI4X0X7BPJACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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