FDA.reportPublic FDA data

Pain Relieving Cream Lidocaine

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:30

Label at a glance#

ProductPain Relieving Cream Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL
Label structure17 sections

Indications and uses

Temporary Pain Relief

Dosage and administration

Adults and children over 12 years clean and dry affected area Apply to affected area not more than 3 to 4 times daily Children 12 years or younger ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

Topical Anasthetic

OTC - ACTIVE INGREDIENT SECTION

Benzyl Alcohol 10%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporary Pain Relief

Do Not Use

OTC - DO NOT USE SECTION

  • On wounds or damaged skin
  • In large quantities
  • With a heating pad
  • if you are allergic to any ingredients of this product

When Using this Product

OTC - WHEN USING SECTION

  • Use only as direcgted
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tightly

Warnings

WARNINGS SECTION

For external Use Only

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years

  • clean and dry affected area
  • Apply to affected area not more than 3 to 4 times daily

Children 12 years or younger

  • ask a doctor

Stop Use and Ask a Doctor If

OTC - STOP USE SECTION

  • Skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

Other Information

SPL UNCLASSIFIED SECTION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, aminomethyl propanol, Butylene glycol, carbome interpolymer type A (allyl sucrose crosslinked), Ceteth-10 phosphate, Cetostearyl alcohol, Dihexadecyl phosphate, Dimethicone, Glyceryl 1-stearate, Hydroxyethly acrylate/sodium acryloydimethyl taurate copolymer, maltodextrin, polysorbate 80, SD alcohol, Steareth-21, water

Distributed By

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Questions

OTC - QUESTIONS SECTION

Call 1-888-296-9067

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4054 GLOBE LIDOCAINE 4 PERCENT PAIN RELIEF CREAM 3OZ REV09 091223 CDER4054 GLOBE LIDOCAINE 4 PERCENT PAIN RELIEF CREAM 3OZ REV09 091223 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1926513benzyl alcohol 10 % / lidocaine HCl 4 % Topical CreamPSN3
1926513benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical CreamSCD3
1926513benzyl alcohol 10 % / lidocaine HCl 4 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-139-03Pain Relieving Cream Lidocaine1 in 1 BOXCREAM13
69396-139-03Pain Relieving Cream Lidocaine85 g in 1 TUBECREAM853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-139PAIN RELIEVING CREAM LIDOCAINE (BENZYL ALCOHOL, LIDOCAINE HCI) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]3Current NDC, 2 package rows20250101_039a2036-54b2-cf28-e063-6294a90a8ce6.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-13969396-139-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALOE VERA LEAFZY81Z83H0XIACT
MALTODEXTRIN7CVR7L4A2DIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZYL ALCOHOLLKG8494WBHACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
STEARETH-2153J3F32P58IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL 1-STEARATE258491E1RZIACT
POLYSORBATE 806OZP39ZG8HIACT
ALCOHOL3K9958V90MIACT

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
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
ndc (package): 69396-139-03
ndc (product): 69396-139
ndc11 (package): 69396013903
spl id: 2a937989-4dc6-58d5-e063-6294a90a4ea9
spl set id: 039a2036-54b2-cf28-e063-6294a90a8ce6

Reported adverse events (FAERS/openFDA)#

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