Lidocaine And Menthol Roll-on

Lidocaine And Menthol Roll-on
SPL v2
SPL
SPL Set ID 511ee92e-f69c-4d21-aadd-84a06aca00c2
Route
TOPICAL
Published
Effective Date 2021-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g)
Inactive Ingredients
Glycerin Borneol Arnica Montana Flower Polyethylene Glycol, Unspecified Frankincense Oil Boswellia Sacra Whole Dimethyl Sulfone Chondroitin Sulfate (bovine) Glucosamine Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-17
Description

LIDOCAINE AND MENTHOL - L idocaine   4% and Menthol 1 % Roll-On Alexso, Inc   Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Lidocaine 4% and Menthol 1 % Roll-On ​Drug Facts

Purpose

Topical anesthetic Topical anesthetic

Medication Information

Purpose

Topical anesthetic

Topical anesthetic

Description

LIDOCAINE AND MENTHOL - L idocaine   4% and Menthol 1 % Roll-On Alexso, Inc   Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Lidocaine 4% and Menthol 1 % Roll-On ​Drug Facts

Uses

Temporarily relieves pain and itching due to:

  • minor cuts

  • sunburn

  • minor scrapes

  • minor burns

  • insect bites

  • minor skin irritations
Section 42229-5

LIDOCAINE AND MENTHOL - L idocaine   4% and Menthol 1 % Roll-On

Alexso, Inc  

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Lidocaine 4% and Menthol 1 % Roll-On

​Drug Facts

Warnings

​For external use only.

Directions
 adults and children 2 years and older  apply externally to the affected area up to 3 to 4  times a day
 children under 2 years do not use except under the advice and supervision of a physician
Active Ingredient

Lidocaine 4%

Menthol 1%

Other Information
  • May be applied under occlusive dressing.

  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.
Inactive Ingredients

Glycerin, Borneol, Arnica Montana Flower Extract, Polyethylene Glycol (PEG), Frankincense Oil, Boswellia Extract, Methylsulfonylmethane (MSM), Chondroitin Sulfate, Glucosamine Sulfate, Water

Principal Display Panel

Lidocaine 4%   and Menthol 1 % Roll-On

NDC 50488-6541-1

50   mL

Manufactured for:

Alexso, Inc.

Los Angeles, CA 90064

When Using This Product
  • do not use in or near the eyes

  • do not use in large quantities, particularly over raw surfaces or blistered areas

  • do not apply to wounds or damaged skin

  • do not bandage
Stop Use and Ask A Doctor If
  • allergic reaction occurs

  • condition worsens or does not improve within 7 days

  • symptoms clear up and return within a few days

  • redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out of Reach of Children.​

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

Structured Label Content

Uses

Temporarily relieves pain and itching due to:

  • minor cuts

  • sunburn

  • minor scrapes

  • minor burns

  • insect bites

  • minor skin irritations
Section 42229-5 (42229-5)

LIDOCAINE AND MENTHOL - L idocaine   4% and Menthol 1 % Roll-On

Alexso, Inc  

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Lidocaine 4% and Menthol 1 % Roll-On

​Drug Facts

Purpose

Topical anesthetic

Topical anesthetic

Warnings

​For external use only.

Directions
 adults and children 2 years and older  apply externally to the affected area up to 3 to 4  times a day
 children under 2 years do not use except under the advice and supervision of a physician
Active Ingredient (Active ingredient)

Lidocaine 4%

Menthol 1%

Other Information (Other information)
  • May be applied under occlusive dressing.

  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.
Inactive Ingredients (Inactive ingredients)

Glycerin, Borneol, Arnica Montana Flower Extract, Polyethylene Glycol (PEG), Frankincense Oil, Boswellia Extract, Methylsulfonylmethane (MSM), Chondroitin Sulfate, Glucosamine Sulfate, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Lidocaine 4%   and Menthol 1 % Roll-On

NDC 50488-6541-1

50   mL

Manufactured for:

Alexso, Inc.

Los Angeles, CA 90064

When Using This Product (When using this product)
  • do not use in or near the eyes

  • do not use in large quantities, particularly over raw surfaces or blistered areas

  • do not apply to wounds or damaged skin

  • do not bandage
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • allergic reaction occurs

  • condition worsens or does not improve within 7 days

  • symptoms clear up and return within a few days

  • redness, irritation, swelling, pain or other symptoms begin or increase
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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:24.433945 · Updated: 2026-03-14T22:59:21.597537