FDA.reportPublic FDA data

Numbing Cream

Manufacturer
FlexiGo Inc
Effective date
2025-10-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:39:35

Label at a glance#

ProductNumbing Cream
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC-ACTIVE INGREDIENT SECTIONOTC-ACTIVE INGREDIENT SECTIONOTC-ACTIVE INGREDIENT SECTIONOTC-ACTIVE INGREDIENT SECTION

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTIONINDICATIONS & USAGE SECTIONINDICATIONS & USAGE SECTIONINDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTIONDOSAGE & ADMINISTRATION SECTIONDOSAGE & ADMINISTRATION SECTIONDOSAGE & ADMINISTRATION SECTION

OTC - PURPOSE SECTION

OTC-PURPOSE SECTIONOTC-PURPOSE SECTIONOTC-PURPOSE SECTIONOTC-PURPOSE SECTION

WARNINGS SECTION

WARNINGSWARNINGSWarningsWarnings

OTC - DO NOT USE SECTION

OTC-DO NOT USE SECTIONOTC-DO NOT USE SECTIONOTC-DO NOT USE SECTIONOTC-DO NOT USE SECTION

OTC - STOP USE SECTION

OTC-STOP USE SECTIONOTC-STOP USE SECTIONOTC-STOP USEOTC-STOP USE

STORAGE AND HANDLING SECTION

STORAGE AND HANDLINGSTORAGE AND HANDLINGSTORAGE AND HANDLINGSTORAGE AND HANDLING

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC-KEEP OUT OF REACH OF CHILDRENOTC-KEEP OUT OF REACH OF CHILDRENOTC-KEEP OUT OF REACH OF CHILDRENOTC-KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2475473menthol 1 % Topical CreamPSN2
2475473menthol 10 MG/ML Topical CreamSCD2
2475473menthol 1 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85524-2520-1Numbing Cream60 mL in 1 BOTTLECREAM602
85524-2520-2Numbing Cream1 in 1 BOXCREAM12
85524-2520-3Numbing Cream50 mL in 1 BOTTLECREAM502
85524-2520-4Numbing Cream1 in 1 BOXCREAM12

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85524-252085524-2520-1, 85524-2520-2, 85524-2520-3, 85524-2520-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 934Z135WT9208IACT
MENTHOLL7T10EIP3AACTIB

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
Numbing CreamMENTHOLFlexiGo Inc4146fd51-b18c-393d-e063-6294a90a4d9a2025-10-20WarningsExact identifier
ndc (package): 85524-2520-2
ndc (package): 85524-2520-1
ndc (package): 85524-2520-3
ndc (package): 85524-2520-4
ndc (product): 85524-2520
ndc11 (package): 85524252003
ndc11 (package): 85524252002
ndc11 (package): 85524252001
ndc11 (package): 85524252004
spl id: 41a3325b-b949-436d-e063-6394a90ac0f8
spl set id: 4146fd51-b18c-393d-e063-6294a90a4d9a

Reported adverse events (FAERS/openFDA)#

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