FDA.reportPublic FDA data

Hexa-Caine

Manufacturer
Pegasus Laboratories, Inc. | Swati Spentose Private Limited
Effective date
2021-12-28
Label type
OTC ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:41:14

Label at a glance#

ProductHexa-Caine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

Shake well and apply liberally to affected areas. Gently wipe away excess spray around the affected area with sterile gauze or cotton. Repeat as often as necessary for continued relief.

Storage and handling

Store at room temperature 15-30°C (58-86 °F)

Label contents#

Full prescribing information#

INDICATIONS:

INDICATIONS & USAGE SECTION

A combination of ingredients for providing quick, soothing relief associated with minor skin irritation.


CONTAINS:

INACTIVE INGREDIENT SECTION

Benzethonium chloride, lanolin, aloe vera and denatonium benzoate (bitter flavoring agent to deter would licking).

Storage Conditions:

STORAGE AND HANDLING SECTION


Store at room temperature 15-30°C (58-86 °F)


DIRECTIONS FOR USE:

DOSAGE & ADMINISTRATION SECTION

Shake well and apply liberally to affected areas. Gently wipe away excess spray around the affected area with sterile gauze or cotton. Repeat as often as necessary for continued relief.

ACTIVE INGREDIENTS:

DOSAGE FORMS & STRENGTHS SECTION

Lidocaine HCl, 2.46%


GENERAL PRECAUTIONS SECTION

For animal use only.
Keep out of reach of children and pets.
For external use only.

Avoid contact with eyes. Do not use on severely traumatized or bleeding skin. If undue skin irritation develops or increases, discontinue use and consult your veterinarian.

Principal Display Panel:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRN PHARMACAL

HEXA-CAINE ™

Topical Anti-Itch Spray With Wound Licking Deterrent

for Dogs, Cats, and Horses

NET CONTENTS:

4 FLUID OUNCES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hexacaine Bottle Label 06-2020Hexacaine Bottle Label 06-2020

Hexacaine Bottle Label 06-2020
Hexacaine Bottle Label 06-2020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1545297Hexa-Caine Anti-Itch 2.46 % Topical SprayPSN4
1545295lidocaine HCl 2.46 % Topical SprayPSN4
1545297lidocaine hydrochloride 24.6 MG/ML Topical Spray [Hexa-Caine]SBD4
1545295lidocaine hydrochloride 24.6 MG/ML Topical SpraySCD4
1545297Hexa-Caine 2.46 % Topical SpraySY4
1545297Hexa-Caine 24.6 MG/ML Topical SpraySY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49427-434-04Hexa-Caine118 mL in 1 BOTTLE, SPRAYSPRAY1184
49427-434-04Hexa-Caine12 in 1 CARTONSPRAY124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49427-434HEXA-CAINE (LIDOCAINE HCL) SPRAY [PEGASUS LABORATORIES, INC.]42 package rows20211229_914fbb95-1280-41eb-93d7-e2f6d2ce96d2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A1
LIDOCAINEACTIVE MOIETY98PI2009871

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49427-43449427-434-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 16 · 302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.23c8f711-e458-479a-9ab0-dcc851311e242026-09-10Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine ViscousLIDOCAINE HYDROCHLORIDEREMEDYREPACK INC.6f8d20d2-6a91-4a5b-bfe8-f1baada384422026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
XYLOCAINE MPFLIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst1986c302-82a0-95a9-e063-6294a90a33392026-09-02Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma9920daef-b156-4a14-b641-f714191ffb5c2026-09-02Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEREMEDYREPACK INC.f824b48c-7039-4ce1-b3df-b3597aba5beb2026-08-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
HUSTLE BUTTER NUMBINGLIDOCAINE HYDROCHLORIDEH.B.D. D.I.S.T. INC.d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e2026-08-24WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ad1ef0a8-88db-4648-c098-d009eaeb4e5b2026-08-20Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMajor Pharmaceuticals04e8dd94-93a8-427d-81ab-a95793d86c362026-08-18Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDESentiss Pharmaceuticals LLC9b2d4f69-0c84-4956-b5c0-b4410acf62e02026-08-12Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.3b2dd84e-cee8-4e58-d494-395a65a353a02026-08-05Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.9c18eaf1-4a0b-4916-70b2-88a8274947112026-08-05Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC46404c7b-2ea4-e47b-e063-6294a90a779f2026-08-03Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine MPFLIDOCAINE HYDROCHLORIDESportpharm LLC50aa6133-0776-4714-9821-fe8581f635ca2026-07-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC573a7298-b02e-230c-e063-6294a90a269c2026-07-22Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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