Zovacil 5

Manufacturer
EUROTAS PHARMACEUTICALS, LLC
Effective date
2021-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:12

Label at a glance#

ProductZovacil 5
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For the temporary relief of pain, soreness or burning. For temporary relief of anorectal discomfort associated with anorectal disorders or inflammation.

Dosage and administration

For adults, when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area not more than 6 times daily. Children under 12 years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 5.0% w/w

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain, soreness or burning. For temporary relief of anorectal discomfort associated with anorectal disorders or inflammation.

Warnings

WARNINGS SECTION

For external use only
Avoid contact with eyes
Do not exceed the recommended daily dosage unless director by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using a finger or any medical device or applicator.
Stop use and ask doctor if
• Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use.
Keep out of reach of children
• If a product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults, when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product.
Apply externally to the affected area not more than 6 times daily. Children under 12 years of age: consult a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Isoprpoyl Palmitate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Questions or Comments?

SPL UNCLASSIFIED SECTION

FDA Registered: NDC No 82067-100-60
Toll -Free 1-844-EUROTAS

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82067-001-012023-01-30C16284748780-1f386c64a-1f79-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82067-001-01Zovacil 560 g in 1 TUBECREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82067-001ZOVACIL 5 (LIDOCAINE HYDROCHLORIDE) CREAM [EUROTAS PHARMACEUTICALS, LLC]1Legacy NDC, 1 package rows20220101_cc486e0d-984f-4b3d-9dde-ae6140cd7869.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82067-00182067-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d09dc379-01c0-65f3-e053-2995a90aa3efcc486e0d-984f-4b3d-9dde-ae6140cd78692021-11-12WarningsExact identifier
spl id: d09dc379-01c0-65f3-e053-2995a90aa3ef
spl set id: cc486e0d-984f-4b3d-9dde-ae6140cd7869

Reported adverse events (FAERS/openFDA)#

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