79740-011

79740-011
SPL v1
SPL
SPL Set ID ebe98b71-1f34-4d40-e053-2a95a90a4c02
Route
TOPICAL
Published
Effective Date 2022-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.5 g) Lidocaine (4 g)
Inactive Ingredients
Sialyl Lewis A Ginger Crocus Sativus Flower Artemisia Princeps Leaf Ethyl Vanillin Water Borneol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-10-26

Description

Lidocaine 4%, Menthol 2.5%


Medication Information

Warnings and Precautions

Wamings

For extemal use only .

Indications and Usage

Use for the temporary relief of pain

Description

Lidocaine 4%, Menthol 2.5%

Section 50565-1

If pregnant or breast-feeding , ask a health professional before use . Keep out of reach of children and pets. If swallowed , get medical help or contact a Poison Control Center right away

Section 51727-6

Ginger Extract

Saffron Extract

Water

Mugwort Leaf Extract

Vanillyn Butyl

Borneol

Carbohydrates

Section 51945-4

79740-011-01

79740-011-02

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine 4%,

Menthol 2.5%

Directions

Adults and children 12 years of age and older

apply a thin layer to affected area every 6-8 hours , not more han 3-4 times daily

massage until thoroughly absorbed into skin

wash hands with soap and water after each usemore than 3 to 4 times daily

Children under 12 years of age : consult a doctor


Structured Label Content

Indications and Usage (34067-9)

Use for the temporary relief of pain

Warnings and Precautions (34071-1)

Wamings

For extemal use only .

Section 50565-1 (50565-1)

If pregnant or breast-feeding , ask a health professional before use . Keep out of reach of children and pets. If swallowed , get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Ginger Extract

Saffron Extract

Water

Mugwort Leaf Extract

Vanillyn Butyl

Borneol

Carbohydrates

Section 51945-4 (51945-4)

79740-011-01

79740-011-02

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%,

Menthol 2.5%

Directions

Adults and children 12 years of age and older

apply a thin layer to affected area every 6-8 hours , not more han 3-4 times daily

massage until thoroughly absorbed into skin

wash hands with soap and water after each usemore than 3 to 4 times daily

Children under 12 years of age : consult a doctor


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)