OptimV Anti-Itch Maximum Strength Cream (KENIL)

Manufacturer
Pharmadel LLC
Effective date
2024-11-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:49:15

Label at a glance#

ProductOptimV Anti-Itch Maximum Strength
Active ingredientBENZOCAINE, RESORCINOL
Label structure8 sections

Dosage and administration

adults and children 12 years and older: apply a finger tip amount to the affected areas not more than 3 to 4 times daily children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Resorcinol 3%

OTC - PURPOSE SECTION

Active ingreditents Purpose
Benzociane 20% ...............External analgesic
Resorcinol 3% ...................External analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves itching.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

  • this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other –caine anesthetics
  • over large areas of the body
  • if you have unusual or abnormal vaginal discharge except under the supervision of a physician
Stop use and ask doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days, or clear up and occur again within a few days
If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

seek professional advice before taking this product.

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 12 years and older: apply a finger tip amount to the affected areas not more than 3 to 4 times daily
  • children under 12 years: ask a doctor

Other Information

OTHER SAFETY INFORMATION

  • do not use if foil seal under cap is punctured or missing
  • store at 20°-25°C (68°F-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe, carbomer 1342, cetyl alcohol, cholecalciferol (vitamin D), corn oil, dl-alpha- tocopherol (vitamin E), edetate disodium, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, lanolin, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, retinol (vitamin A), stearic acid, stearyl alcohol, trolamine, water.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP 1oz Optim V AI CreamPDP 1oz Optim V AI Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-300OPTIMV ANTI-ITCH MAXIMUM STRENGTH (BENZOCAINE, RESORCINOL) CREAM [PHARMADEL LLC]4Legacy NDC20241120_e064940f-83d7-85b6-e053-2995a90aec92.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-30055758-300-07, 55758-300-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
437f93d5-d590-6b3a-e063-6294a90ac268e064940f-83d7-85b6-e053-2995a90aec922025-11-13WarningsExact identifier
spl set id: e064940f-83d7-85b6-e053-2995a90aec92

Reported adverse events (FAERS/openFDA)#

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