SPL v1
SPL
SPL Set ID 42c70681-494b-47c9-e063-6394a90a80be
Route
TOPICAL
Published
Effective Date 2025-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g) Menthol (0.01 g)
Inactive Ingredients
Water Propylene Glycol Tartaric Acid Polyacrylic Acid (250000 Mw) Phenoxyethanol Isopropyl Myristate Aloe Vera Leaf Lavender Oil .alpha.-tocopherol, D- Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-03

Description

Active Ingredient Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic) Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use

Temporary relief of pain

Do not use

• On large areas of the body or on cut, irritated, or swollen skin not apply to wounds or damaged skin • on puncture wounds • for more than one week without consulting a doctor.

When using this product

• Use only as directed. Read and follow all directions and warnings on this label

• Do not allow contact with eyes and mucous membranes

• Do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use

• Do not use at the same time as other topical analgesics

Stop use if

• Condition worsens

• Redness is present

• Irritation develops

• Symptoms persist for more than 7 days or clear up and occur within a few days

Dosage and Administration

Directions

Adults and children 12 years of age and over:

  • Apply a thin layer to the affected area for 6 to 8 hours
  • Not to exceed 3 applications in a 24 hour period

Children under 12 years old: Consult a doctor

Description

Active Ingredient Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic) Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

Section 43685-7

Flammable

• Keep away from fire or flame

Section 50565-1

Keep out of reach of children

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

Section 50569-3

Ask a doctor if

• Condition worsens

• Redness is present

• Irritation develops

• Symptoms persist for more than 7 days or clear up and occur within a few days

Section 51727-6

Inactive Ingredients

Aloe Vera Extract, Carbomer, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water

Section 51945-4

Section 53414-9

If pregnant or breast-feeding

  • Ask a health professional before use
Section 55105-1

Purpose

(Lidocaine) Topical Anesthetic

(Menthol) Topical Analgesic

Section 55106-9

Active Ingredient

Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)

Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

Section 60561-8

Child-resistant packaging. Close the cap tightly after use.


Structured Label Content

Indications and Usage (34067-9)

Use

Temporary relief of pain

Do not use

• On large areas of the body or on cut, irritated, or swollen skin not apply to wounds or damaged skin • on puncture wounds • for more than one week without consulting a doctor.

When using this product

• Use only as directed. Read and follow all directions and warnings on this label

• Do not allow contact with eyes and mucous membranes

• Do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use

• Do not use at the same time as other topical analgesics

Stop use if

• Condition worsens

• Redness is present

• Irritation develops

• Symptoms persist for more than 7 days or clear up and occur within a few days

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and over:

  • Apply a thin layer to the affected area for 6 to 8 hours
  • Not to exceed 3 applications in a 24 hour period

Children under 12 years old: Consult a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 43685-7 (43685-7)

Flammable

• Keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50569-3 (50569-3)

Ask a doctor if

• Condition worsens

• Redness is present

• Irritation develops

• Symptoms persist for more than 7 days or clear up and occur within a few days

Section 51727-6 (51727-6)

Inactive Ingredients

Aloe Vera Extract, Carbomer, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding

  • Ask a health professional before use
Section 55105-1 (55105-1)

Purpose

(Lidocaine) Topical Anesthetic

(Menthol) Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient

Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)

Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

Section 60561-8 (60561-8)

Child-resistant packaging. Close the cap tightly after use.


Advanced Ingredient Data


Raw Label Data

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