MAMISAN- lidocaine hydrochloride, menthol ointment

Mamisan by

Drug Labeling and Warnings

Mamisan by is a Otc medication manufactured, distributed, or labeled by Miramar Cosmetics, Inc DBA Miramar Lab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Lidocaine HCl 4%

Menthol 1%

Purpose

Pain relieving

Use

For the temporary relief of pain

Warnings

For external use only.

When using this product 

avoid contact with the eyes  do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if 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. If swallowed, get medical help or contact a Poison Control Center right away.

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 years of age: Consult a doctor.

Other information

Store in a cool, dry place 68-77°F (23-25°C)

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

MAX STRENGTH

Distributed by: Plantimex Distributors Inc
7577 Airway Rd #105,
San Diego, CA 92154
To report a serious adverse event, contact the distributor at the address above

Packaging

INGREDIENTS AND APPEARANCE

MAMISAN 
lidocaine hydrochloride, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79974-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
D&C RED NO. 17 (UNII: ND733RX3JN)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
EUCALYPTUS OIL (UNII: 2R04ONI662)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79974-216-03	100 g in 1 JAR; Type 0: Not a Combination Product	09/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/02/2024

Labeler - Miramar Cosmetics, Inc DBA Miramar Lab (012873243)

Establishment
Name	Address	ID/FEI	Business Operations
Miramar Cosmetics, Inc DBA Miramar Lab		012873243	manufacture(79974-216)