FDA.reportPublic FDA data

Lidocaine Plus Maximum Strength Pain Relieving Cream

Manufacturer
Prime Enterprises Inc.
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:21:18

Label at a glance#

ProductLidocaine Plus Maximum Strength Pain Relieving Cream
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

Dosage and administration

Adults and children 2 years of age and older : Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age : Consult a doctor. Always tighten cap firmly after each use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Cream

Indications (Uses)

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with the eyes.

OTC - ASK DOCTOR SECTION

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.
  • Always tighten cap firmly after each use

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5

Other Information

OTHER SAFETY INFORMATION

Questions or Comments?

Call 1-888-263-9808

Lidocaine Plus Maximum Strength Pain Relieving Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-012358443-0123-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURETH-7Z95S6G8201IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABENA2I8C7HI9TIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
PROPYLPARABENZ8IX2SC1OHIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
aa8122dd-0266-12aa-e053-2a95a90aaf8e2c26e249-2659-6214-e054-00144ff88e882020-07-15WarningsExact identifier
spl id: aa8122dd-0266-12aa-e053-2a95a90aaf8e
spl set id: 2c26e249-2659-6214-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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