Mamisan®

Mamisan®
SPL v2
SPL
SPL Set ID 4402e900-c6e9-4f32-8cc4-c84014384a9f
Route
TOPICAL
Published
Effective Date 2024-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Butylated Hydroxytoluene D&c Red No. 17 D&c Yellow No. 11 Eucalyptus Oil White Petrolatum Soybean Oil Glyceryl Monostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-02

Description

Lidocaine HCl 4% Menthol 1%

Purpose

Pain relieving


Medication Information

Purpose

Pain relieving

Description

Lidocaine HCl 4% Menthol 1%

Use

• For the temporary relief of pain

Section 42229-5

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

Section 50565-1

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

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.

Packaging

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.

Drug Facts

Other Information

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

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Inactive Ingredients

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


Structured Label Content

Use

• For the temporary relief of pain

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Purpose

Pain relieving

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.

Packaging

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.

Drug Facts

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Lidocaine HCl 4%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

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