LeedFrost Cream (lidocaine 5%)

Manufacturer
Koru Pharmaceuticals Co., Ltd. | Koru Pharmaceutical
Effective date
2020-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:10:29

Label at a glance#

ProductLeedFrost Cream (lidocaine 5%)
Active ingredientLIDOCAINE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain.

WARNINGS SECTION

For External Use Only.

OTC - DO NOT USE SECTION

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with tey eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period
  • Children 12 years or younger: ask a doctor

INACTIVE INGREDIENT SECTION

Carbomer 940, Cetanol, Glycerin, Clyceryl Monostearate, Isopropyl Myristate, Light Liquid Paraffin, Methylparaben, Polysorbate 60, Porpylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80393-10080393-100-01, 80393-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
cf59e64c-7747-e3fe-e053-2a95a90a8640b1b700e3-b320-7809-e053-2995a90a365b2021-10-21WarningsExact identifier
spl set id: b1b700e3-b320-7809-e053-2995a90a365b

Reported adverse events (FAERS/openFDA)#

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