myDerm Numbing Roll-On

Manufacturer
Inspec Solutions LLC.
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:41:38

Label at a glance#

ProductmyDerm Numbing Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine HCI 5%

OTC - PURPOSE SECTION

Uses Helps relieve anorectal symptoms (pain, soreness, burning, itching). Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

WARNINGS SECTION

Warnings For external use only

OTC - WHEN USING SECTION

When using this product • avoid contact with the eyes or mucous membranes.

OTC - STOP USE SECTION

Stop use and ask doctor if • condition worsens, or if symptoms persist for more than 7 days, or dear up and reoccur again within a few days. Do not use if pregnant or breast-feeding.

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 immediately.

PREGNANCY SECTION

Do not use if pregnant or breast-feeding.

INDICATIONS & USAGE SECTION

Directions • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2

INACTIVE INGREDIENT SECTION

Inactive Ingredients Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol,

C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl

Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl

Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl

Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21 , Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

myDerm Numbing Roll-on 5% LidocainemyDerm Numbing Roll-on 5% Lidocaine

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72667-058-012025-02-01C16284748780-12cef2736-71bc-d83d-e063-dadaa90ab31fmyDerm Numbing Roll-On 5% Lidocaine

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72667-058MYDERM NUMBING ROLL-ON (INSPEC SOLUTIONS LLC) CREAM [INSPEC SOLUTIONS LLC.]2Legacy NDC20250202_f14da33b-2eaf-dc2c-e053-2a95a90a3203.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
72667-05872667-058-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
4af4bd0a-836d-ab58-e063-6294a90a283df14da33b-2eaf-dc2c-e053-2a95a90a32032026-02-16WarningsExact identifier
spl set id: f14da33b-2eaf-dc2c-e053-2a95a90a3203

Reported adverse events (FAERS/openFDA)#

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