FDA.reportPublic FDA data

Ziclovin Oral Pain Relief Gel (K)

Manufacturer
Pharmadel LLC
Effective date
2024-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:49:18

Label at a glance#

ProductZiclovin Oral Pain Relief
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain due to fever blisters cold sores antiseptic to help prevent infection

Dosage and administration

adults and children 2 years of age and older: Clean the affected area. Apply a small amount to affected not more than 3 times daily. May be covered with a sterile bandage. If bandaged, let first dry. children under 2 years of age : do not use, consult a doctor

Label contents#

Full prescribing information#

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients Purposes
Benzalkonium chloride 0.1%........................Topical antiseptic
Benzocaine 20%..........................................Fever blister and cold sore treatment

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain due to

  • fever blisters
  • cold sores
  • antiseptic to help prevent infection

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use

OTC - DO NOT USE SECTION

  • longer than 1 week
  • on large areas of the body
  • in the eyes

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • in case of deep or puncture wounds, animal bites, or serious burns

When using this product

OTC - WHEN USING SECTION

  • you may feel a brief stinging sensation after application that will go away shortly thereafter

Stop use and ask a dentist or doctor if

OTC - STOP USE SECTION

  • a rash or irritation develops
  • condition persists or worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: Clean the affected area. Apply a small amount to affected not more than 3 times daily. May be covered with a sterile bandage. If bandaged, let first dry.
  • children under 2 years of age: do not use, consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store between 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, carboxymethylcellulose sodium, FD&C yellow #6, glycerin, polyethylene glycol, saccharin sodium, sorbic acid, water

Questions?

OTC - QUESTIONS SECTION

Dist. by/por: PHARMADEL LLC

New Castle, DE 19720

Questions? +1-866-359-3478

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP Ziclovin Oral PainPDP Ziclovin Oral Pain

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-438ZICLOVIN ORAL PAIN RELIEF (BENZALKONIUM CHLORIDE, BENZOCAINE) GEL [PHARMADEL LLC]2Unmatched20241116_2292b69b-af1e-41f3-e063-6394a90ad37a.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-43855758-438-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SORBIC ACIDX045WJ989BIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
437f93d5-d591-6b3a-e063-6294a90ac2682292b69b-af1e-41f3-e063-6394a90ad37a2025-11-13WarningsExact identifier
spl set id: 2292b69b-af1e-41f3-e063-6394a90ad37a

Reported adverse events (FAERS/openFDA)#

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