FDA.reportPublic FDA data

Mamisan Pain Relieving Ointment

Manufacturer
PLANTIMEX DISTRIBUTORS INC
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:16:53

Label at a glance#

ProductMamisan Pain Relieving
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Pain relieving

Use

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes

do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

Store in a cool, dry place 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT, D&C Red #17, D&C Yellow #11, Eucalyptus Oil, Petrolatum, Soybean Oil, Wax.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:72816-000-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72816-00072816-000-01, 72816-000-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
D&C RED NO. 17ND733RX3JNIACT
D&C YELLOW NO. 1144F3HYL954IACT
EUCALYPTUS OIL2R04ONI662IACT
PETROLATUM4T6H12BN9UIACT
SOYBEAN OIL241ATL177AIACT
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
1b4045cb-4123-6b27-e063-6294a90aa757b3c2759d-d064-3522-e053-2a95a90add732024-06-19WarningsExact identifier
spl set id: b3c2759d-d064-3522-e053-2a95a90add73

Reported adverse events (FAERS/openFDA)#

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