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#
Contacts and useful links#
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
Products#
Every source-derived product name is available through these pages.
- LeedFrost Cream (lidocaine 5%)
- Lidocaine
- METHYLPARABEN
- POLYSORBATE 60
- ISOPROPYL MYRISTATE
- STEARIC ACID
- PETROLATUM
- LIGHT MINERAL OIL
- PROPYLENE GLYCOL
- TROLAMINE
- WATER
- GLYCERIN
- CARBOMER 940
- CETYL ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80393-100 | 80393-100-01, 80393-100-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| cf59e64c-7747-e3fe-e053-2a95a90a8640 | b1b700e3-b320-7809-e053-2995a90a365b | 2021-10-21 | Warnings | b1b700e3-b320-7809-e053-2995a90a365b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
