FDA.reportPublic FDA data

Mamisan Pain Relieving Cream Lidocaine Plus Menthol

Manufacturer
PLANTIMEX DISTRIBUTORS INC
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:16:49

Label at a glance#

ProductMamisan Pain Relieving Cream Lidocaine Plus Menthol
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure6 sections

Dosage and administration

a dults and children over 12 years of age and older: apply a thin layer to affected area 6 to 8 hours, not to exceed 3 applications in a 24 hour period. children 12 years or younger: ask a doctor BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Topical analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use with a medicated patch
  • avoid contact with the eyes and mucous membranes.
  • a transient burning sensation may occur upon application but generally disappears in several days.

Stop use and ask 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health-professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • a dults and children over 12 years of age and older:

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

  • children 12 years or younger: ask a doctor
  • BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified water, eucalyptus, PNC 400 and phenochem.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72816-00172816-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EUCALYPTUS GUM72T9EZC2VXIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
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
1b406129-1c92-6761-e063-6394a90a9b1628078f3e-5bc4-4a98-b3cb-32c0af4284692024-06-19WarningsExact identifier
spl set id: 28078f3e-5bc4-4a98-b3cb-32c0af428469

Reported adverse events (FAERS/openFDA)#

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