WelAhead by Welmate Lidocaine 5% Roll-on

Manufacturer
OTC PHARM LLC
Effective date
2025-05-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:01:21

Label at a glance#

ProductWelAhead by Welmate Lidocaine 5% Roll-on
Active ingredientLIDOCAINE HYDROCHLORIDE ANHYDROUS
Label structure8 sections

Dosage and administration

Adults and children over 12 years: apply a thin layer to affeced area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period Children 12 years and younger: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 5%

Purporse

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily Relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Do not use

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than week without consulting a doctor

When using this product:

  • use cnly as directed. Read and follow all directions and warnings on this carton
  • do not allow contact with the eyes and mucous membranes
  • do not bandage or apply a local heat (such as heating pads) to the area of use

Stop use and aska doctor if

  • condition worsens
  • skin reactions occur, such as rash, itching, redness, irritation, pain, and swelling
  • symptoms persist for more than 7 days or clear up and occur again within a days

Flammable

  • keep away from fire or flame

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

apply a thin layer to affeced area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

Children 12 years and younger: ask a doctor

Inactive Ingrediants

INACTIVE INGREDIENT SECTION

purified water, ethyl alcohol, propylene glycol, polysorbate 20, triethanolamine, phenoxyethanol, ethylhexylglycerin,

potassium carbomer, aloe vera, glycerin, chonüoitin sulfate, glucosamine sulfate, methylsulfonylmethane

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2670601lidocaine HCl 5 % Topical SolutionPSN2
2670601lidocaine hydrochloride 50 MG/ML Topical SolutionSCD2
2670601lidocaine hydrochloride 5 % Topical SolutionSY2

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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83833-101-03WelAhead by Welmate Lidocaine 5% Roll-on90 mL in 1 BOTTLE, WITH APPLICATORSOLUTION902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83833-101WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON (LIDOCAINE 5%) SOLUTION [OTC PHARM LLC]2Current NDC, 1 package rows20250523_0b75e83e-8c7b-6247-e063-6294a90ac413.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83833-10183833-101-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
WelAhead by Welmate Lidocaine 5% Roll-onLIDOCAINE 5%OTC PHARM LLC0b75e83e-8c7b-6247-e063-6294a90ac4132025-05-21WarningsExact identifier
ndc (package): 83833-101-03
ndc (product): 83833-101
ndc11 (package): 83833010103
spl id: 35a93f2b-396d-1532-e063-6394a90a7c83
spl set id: 0b75e83e-8c7b-6247-e063-6294a90ac413

Reported adverse events (FAERS/openFDA)#

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