FDA.reportPublic FDA data

CICLOFERON

Manufacturer
Laboratorios Liomont, S.A. de C.V.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:07

Label at a glance#

ProductCICLOFERON
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

provides temporary relief of pain associated with cold sores and fever blisters first aid to help protect against infection in minor cuts, scrapes, burns

Dosage and administration

clean the affected area apply a small amount of this product to the affected area 1 to 3 times daily may be covered with a sterile bandage children under 12 years of age, consult a doctor

Storage and handling

store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Lidocaine Hydrchloride 2%

Purpose

OTC - PURPOSE SECTION

Topical antiseptic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • provides temporary relief of pain associated with cold sores and fever blisters
    • first aid to help protect against infection in minor cuts, scrapes, burns

Warnings

WARNINGS SECTION

For external use only:

Do not use in the eyes or apply over large areas of the body. In case of deep puncture wounds, animal bites, or serious burns, consult a doctor.

Do not use

OTC - DO NOT USE SECTION

  • for more than 7 days unless told to do so by a doctor
  • more than directed
  • if you are allergic to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of this product to the affected area 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 12 years of age, consult a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

hypromellose, methylparaben, propylene glycol, water, polysorbate 80

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1431682benzalkonium chloride 0.13 % / lidocaine HCl 2 % Topical GelPSN2
1431687CICLOFERON 0.13 % / 2 % Topical GelPSN2
1431687benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical Gel [Cicloferon]SBD2
1431682benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical GelSCD2
1431682benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % Topical GelSY2
1431687Cicloferon (benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % ) Topical GelSY2

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
59208-002-04CICLOFERON4 g in 1 TUBEGEL42
59208-002-04CICLOFERON1 in 1 CARTONGEL12
59208-002-05CICLOFERON4 g in 1 TUBEGEL42
59208-002-05CICLOFERON1 in 1 CONTAINERGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59208-002CICLOFERON (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) GEL [LABORATORIOS LIOMONT, S.A. DE C.V.]2Current NDC, Legacy NDC, 4 package rows20241019_89081ef8-9721-a476-e053-2995a90ae0de.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59208-00259208-002-04, 59208-002-05

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
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CICLOFERONBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDELaboratorios Liomont, S.A. de C.V.89081ef8-9721-a476-e053-2995a90ae0de2024-10-17WarningsExact identifier
ndc (package): 59208-002-04
ndc (package): 59208-002-05
ndc (product): 59208-002
ndc11 (package): 59208000204
ndc11 (package): 59208000205
spl id: 24b2e848-505d-3cf9-e063-6394a90a16d7
spl set id: 89081ef8-9721-a476-e053-2995a90ae0de

Reported adverse events (FAERS/openFDA)#

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