Lidocaine HCI 4% Cream

Manufacturer
Trifluent Pharma, LLC
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:52:16

Label at a glance#

ProductLidocaine HCI
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 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, and rashes due to poison ivy, poison oak, or poison sumac.

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.

Label contents#

Full prescribing information#

Lidocaine HCI 4% Cream - Topcial Analgesic Pain Relieving Cream

OTC - PURPOSE SECTION

Active Ingredient

Lidocaine HCI 4%...................................Topical 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, and rashes due to poison ivy, poison oak, or poison sumac.

Warnings

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes

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

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

If pregnant or breast-feeding, ask a health professional before use.

.

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

OTHER SAFETY INFORMATION

Store at room temperature 68° to 77°F (20 to 25°C); excursion permitted to 58°F to 86°F (15° to 30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alkyl (C12-15) Benzoate, Butylparaben, Carica Papaya (Papaya) Fruit Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Dimethicone, Disodium EDTA, Emulsifying Wax, Ethylparaben, Glycerin, Glyceryl Stearate , Hydrogenated Polydecene, Hydroxypropylcellulose, Isobutylparaben, Lavandula Angustifolia (Lavender) Flower Extract, Methylparaben, PEG 100, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Sodium Lactate, Sodium Polyacrylate, Trideceth-6, Xanthan Gum

Questions or comments?

OTC - QUESTIONS SECTION

(210) 944-6920

HOW SUPPLIED SECTION

Lidocaine HCI 4% Cream

NDC 73352-204-60

1oz. (30g) tube

MANUFACTURED FOR:

Trifluent Pharma, LLC

San Antonio, TX 78213

204-60

REV01 08/2025

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP out of reach of children. If swallowed, get medical help anor contact a Poison control Center (1-800-222-1222) right aways.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label-1ALabel-1A

Label-2ALabel-2A

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130373352204601GTIN-13: 0373352204601
EAN-13: 0373352204601
GTIN-12: 373352204601
UPC-A: 373352204601
GTIN storage (14 digits): 00373352204601
Label-2A.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-204-60Lidocaine HCI30 g in 1 TUBECREAM301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-204-60GM - Gram73352-204c4acec88-661c-4dcd-bd00-ce722226e95612026-02-05

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73352-20473352-204-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
Lidocaine HCILIDOCAINE HCITrifluent Pharma, LLC47f7f06b-720e-eeec-e063-6294a90ae8232026-01-09WarningsExact identifier
ndc (package): 73352-204-60
ndc (product): 73352-204
ndc11 (package): 73352020460
spl id: 47f7f06b-720f-eeec-e063-6294a90ae823
spl set id: 47f7f06b-720e-eeec-e063-6294a90ae823

Reported adverse events (FAERS/openFDA)#

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