FDA.reportPublic FDA data

MediNumb

Manufacturer
Valekista Limited
Effective date
2017-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:11

Label at a glance#

ProductMediNumb
Active ingredientLidocaine
Label structure10 sections

Dosage and administration

Adults and children 2 years and older clean the affected area apply to affected area not more than 3 to 4 times daily remove residue if desired Children under 2 years old: Consult a doctor

Storage and handling

Store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

Not for prolonged use

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clears up and occurs again within a few days
  • rash or irritation develops, persists or increases

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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: 800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older

  • clean the affected area
  • apply to affected area not more than 3 to 4 times daily
  • remove residue if desired
  • Children under 2 years old: Consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, arginine, benzophenone-4, cetyl alcohol, dimethyl sulfoxide, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol; (and) caprylyl glycol (and) potassium sorbate (and) water (and) hexylene glycol, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

SPL UNCLASSIFIED SECTION

Distributed by: Valekista Limited, Pacific Plaza, Western District, HK

PRINCIPAL DISPLAY PANEL - 56 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDINUMB™

4% Lidocaine Cream
Pain Relieving Topical Anesthetic
Medicated Cream to Numb The Skin

MAXIMUM STRENGTH
NET WT. 2oz.(56g)

Principal Display Panel - 56 g Tube Box
Principal Display Panel - 56 g Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN1
1421893lidocaine 40 MG/ML Topical CreamSCD1
1421893lidocaine 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71383-024-02MediNumb1 in 1 BOXCREAM11
71383-024-02MediNumb56 g in 1 TUBECREAM561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71383-024MEDINUMB (LIDOCAINE) CREAM [VALEKISTA LIMITED]1Current NDC, Legacy NDC, 2 package rows20170811_0e43648d-3dae-4faf-a6b4-d21c062e32e1.zip

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
71383-02471383-024-02

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
ALOE VERA LEAFZY81Z83H0XIACT
Arginine94ZLA3W45FIACT
SULISOBENZONE1W6L629B4KIACT
Cetyl Alcohol936JST6JCNIACT
Dimethyl SulfoxideYOW8V9698HIACT
Tea Tree OilVIF565UC2GIACT
PhenoxyethanolHIE492ZZ3TIACT
Caprylyl Glycol00YIU5438UIACT
Potassium Sorbate1VPU26JZZ4IACT
Hexylene GlycolKEH0A3F75JIACT
Water059QF0KO0RIACT
Jojoba Oil724GKU717MIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
Stearic Acid4ELV7Z65APIACT

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
MediNumbLIDOCAINEValekista Limited0e43648d-3dae-4faf-a6b4-d21c062e32e12017-07-06WarningsExact identifier
ndc (package): 71383-024-02
ndc (product): 71383-024
ndc11 (package): 71383002402
spl id: 906c3414-a2c8-4038-9d38-0fd0fbbfdf94
spl set id: 0e43648d-3dae-4faf-a6b4-d21c062e32e1

Reported adverse events (FAERS/openFDA)#

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