FDA.reportPublic FDA data

Lidocaine 4% Cream

Manufacturer
Stratus Pharmaceuticals Inc | Tarmac Products Inc
Effective date
2024-09-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:19:58

Label at a glance#

ProductLidocaine
Active ingredientLidocaine
Label structure11 sections

Indications and uses

for the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites 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: do not use, consult a doctor.

Storage and handling

Store at 20°C to 25°C (68°F to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% (4g in 100g)

Purpose

OTC - PURPOSE SECTION

Local analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching associated with

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and consult a 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

SPL UNCLASSIFIED SECTION

Lidocaine is NOT approved by FDA to treat teething pain and should NOT be given to infants and young children for this use.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

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: do not use, consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at 20°C to 25°C (68°F to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl acetate.

Questions?

OTC - QUESTIONS SECTION

Call us at (800) 442-7882

SPL UNCLASSIFIED SECTION

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STRATUS
PHARMACEUTICALS INC

NDC 58980-824-30

Net WT. 1 oz. / 28.35 g

LIDOCAINE CREAM
4%

PAIN RELIEVING CREAM

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box
PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN2
1421893lidocaine 40 MG/ML Topical CreamSCD2
1421893lidocaine 4 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-824-05Lidocaine1 in 1 BOXCREAM12
58980-824-05Lidocaine14.17 g in 1 TUBECREAM14.172
58980-824-15Lidocaine5 in 1 BOX, UNIT-DOSECREAM52
58980-824-15Lidocaine5 g in 1 TUBECREAM52
58980-824-30Lidocaine28.35 g in 1 TUBECREAM28.352
58980-824-30Lidocaine1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-824LIDOCAINE CREAM [STRATUS PHARMACEUTICALS INC]2Current NDC, 6 package rows20240922_e1a8d4a7-01f7-4bab-8d09-875c461b3b61.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-824-05GM - Gram58980-82413fde5f1-ab56-4bf0-b57c-7280acc43dab12024-10-04
58980-824-15GM - Gram58980-8242d5aa8ba-de05-43b4-8a77-5776bb3c148f12024-10-04
58980-824-30GM - Gram58980-824a8dfea61-8933-4b05-83f6-d835c8e9c95812024-02-14

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58980-82458980-824-30, 58980-824-05, 58980-824-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lidocaine98PI200987ACTIB
Acrylamide20R035KLCIIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
Allantoin344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
Benzyl AlcoholLKG8494WBHIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOHEXADECANE918X1OUF1EIACT
Polysorbate 806OZP39ZG8HIACT
Propylene Glycol6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM ACRYLOYLDIMETHYLTAURATE2T9Q6EKI0GIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
SOYBEAN LECITHIN1DI56QDM62IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
LidocaineLIDOCAINEStratus Pharmaceuticals Ince1a8d4a7-01f7-4bab-8d09-875c461b3b612024-09-19WarningsExact identifier
ndc (package): 58980-824-15
ndc (package): 58980-824-30
ndc (package): 58980-824-05
ndc (product): 58980-824
ndc11 (package): 58980082415
ndc11 (package): 58980082405
ndc11 (package): 58980082430
spl id: 6d26e7b3-bcd8-46de-9ae1-6010b4014fc1
spl set id: e1a8d4a7-01f7-4bab-8d09-875c461b3b61

Reported adverse events (FAERS/openFDA)#

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