Ndc 59088-240-16

Ndc 59088-240-16
SPL v5
SPL
SPL Set ID d2a9aeb6-8a94-49e7-ab46-84403560b6c8
Route
TOPICAL
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Carbomer Bisabolol Ethylhexylglycerin Sodium Hydroxide Glycerin Phenoxyethanol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-08
Description

Lidocaine HCL 4% Menthol 1%

Purpose

Topical Anesthetic (Lidocaine HCL 4%) Topical Analgesic (Menthol 1%)

Medication Information

Purpose

Topical Anesthetic (Lidocaine HCL 4%) Topical Analgesic (Menthol 1%)

Description

Lidocaine HCL 4% Menthol 1%

Uses

For the temporary relief of pain and itching associated with:

■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites

■ minor skin irritations

Section 50570-1

■ Do not apply to wounds or damaged skin ■ Do not bandage tightly

Section 51945-4

Manufactured in the USA by:

PureTek Corporation

San Fernando, CA 91340

877-921-7873

Purposes

Topical Anesthetic (Lidocaine HCL 4%)

Topical Analgesic (Menthol 1%)

Warnings

For external use only

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: do not use, consult a doctor.

Other Information

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

Active Ingredients

Lidocaine HCL 4%

Menthol 1%

Inactive Ingredients

Aqua (Purified Water), Bisabolol, Carbomer, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide.

When Using This Product

■ Avoid contact with the eyes

Stop Use and Ask A Doctor If

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Structured Label Content

Uses

For the temporary relief of pain and itching associated with:

■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites

■ minor skin irritations

Section 50570-1 (50570-1)

■ Do not apply to wounds or damaged skin ■ Do not bandage tightly

Section 51945-4 (51945-4)

Manufactured in the USA by:

PureTek Corporation

San Fernando, CA 91340

877-921-7873

Purposes

Topical Anesthetic (Lidocaine HCL 4%)

Topical Analgesic (Menthol 1%)

Warnings

For external use only

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: do not use, consult a doctor.

Other Information (Other information)

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

Active Ingredients (Active ingredients)

Lidocaine HCL 4%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

Aqua (Purified Water), Bisabolol, Carbomer, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide.

When Using This Product (When using this product)

■ Avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:58.433407 · Updated: 2026-03-14T23:10:05.459246