FDA.reportPublic FDA data

MAXIMUM STRENGTH Lidocaine Plus Menthol

Manufacturer
ARMY AND AIR FORCE EXCHANGE SERVICE | Foshan Aqua Gel Biotech Co.,Ltd.
Effective date
2026-08-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-25 01:02:54

Label at a glance#

ProductMAXIMUM STRENGTH Lidocaine Plus Menthol
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

Temporary relief of minor pain

Dosage and administration

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard after single use. Children under 12 years of age: consult a physician.

Storage and handling

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% Topical Anesthetic

Menthol 1% Topical Anesthetic

OTC - PURPOSE SECTION

Topical Anesthetic

USES

INDICATIONS & USAGE SECTION

Temporary relief of minor pain

WARNINGS

WARNINGS SECTION

  • For External use only. Use only as directed.

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.

OTC - DO NOT USE SECTION

■ More than one patch on your body at a time

■ On cut, irritated or swollen skin

■ On puncture wounds

■ For more than one week without consulting a doctor

■ If you are allergic to any active or inactive ingredients

■ If pouch is damaged or opened.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • Contact a physician prior to use.

WHEN USING:

OTC - WHEN USING SECTION

■ Use only as directed

■ Read and follow all directions and warnings on this carton

■ Do not allow contact with the eyes

■ Do not use at the same time as other topical analgesics

■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ Do not microwave

■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain
the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor if

OTC - STOP USE SECTION

■ Condition worsens

■ Redness is present

■ Irritation develops

■ Symptoms persist for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

DIRECTIONS Adults and children 12 years of age and over:

DOSAGE & ADMINISTRATION SECTION

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side
of patch to affected area. Use one patch for up to 12 hours. Discard after single use.
Children under 12 years of age: consult a physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, ethylhexylglycerin, glycerin, iodopropynyl butylcarbamate, kaolin,

petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid,
titanium dioxide, water

STORAGE AND HANDLING SECTION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130614299793019GTIN-13: 0614299793019
EAN-13: 0614299793019
GTIN-12: 614299793019
UPC-A: 614299793019
GTIN storage (14 digits): 00614299793019		9288011_0426_PKG_912_LidoMenthol_for_DailyMed.jpg

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55301-912-052025-12-30C16284748780-12cef2736-79d8-d83d-e063-dadaa90ab31fMAXIMUM STRENGTH Lidocaine Plus Menthol
55301-912-052025-12-30C16284748780-12cef2736-79d8-d83d-e063-dadaa90ab31fMAXIMUM STRENGTH Lidocaine Plus Menthol
55301-912-052025-01-30C16284748780-12cef2736-79d8-d83d-e063-dadaa90ab31fMAXIMUM STRENGTH Lidocaine Plus Menthol
55301-912-052025-01-30C16284748780-12cef2736-79d8-d83d-e063-dadaa90ab31fMAXIMUM STRENGTH Lidocaine Plus Menthol

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
55301-91255301-912-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
IODOCARB603P14DHEBIACT
PETROLATUM4T6H12BN9UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-30full-release2026-06-01 01:29:15

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
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
ndc (package): 55301-912-05
ndc (product): 55301-912
ndc11 (package): 55301091205
spl id: 597cb44e-bfe7-a36a-e063-6294a90ab210
spl set id: 60f72061-d264-424e-b396-5a609076d352

Reported adverse events (FAERS/openFDA)#

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