Lidocaine And Menthol Gel

Lidocaine And Menthol Gel
SPL v1
SPL
SPL Set ID 6dbfccb2-332b-4d45-bacf-0b539420e2f7
Route
ORAL
Published
Effective Date 2021-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4.8 g) Menthol (1.2 g)
Inactive Ingredients
Carbomer Interpolymer Type A (55000 Cps) Aloe Vera Leaf Water Arnica Montana Flower Indian Frankincense Ethylhexylglycerin Glucosamine Sulfate Ilex Paraguariensis Leaf Magnesium Sulfate, Unspecified Dimethyl Sulfone Phenoxyethanol Polysorbate 20 Trolamine Corn

Identifiers & Packaging

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

Description

LIDOCAINE AND MENTHOL - L idocaine   4% and Menthol 1 % Gel 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 % Gel ​Drug Facts

Purpose

Lidocaine 4% ………………………..Topical anesthetic Menthol 1% …………………………Topical analgesic


Medication Information

Purpose

Lidocaine 4% ………………………..Topical anesthetic

Menthol 1% …………………………Topical analgesic

Description

LIDOCAINE AND MENTHOL - L idocaine   4% and Menthol 1 % Gel 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 % Gel ​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 % Gel

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 % Gel

​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
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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Glucosamine Sulfate, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Triethanolamine, Zemea (Corn) Propanediol

Lidocaine 4%   and Menthol 1 % Gel

NDC 50488-6641-1

120 grams

Manufactured for:

Alexso, Inc.

Los Angeles, CA 90064

Principal Display Panel

NDC 50488-6641-1

Lidocaine 4% + Menthol 1%

120 grams

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 % Gel

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 % Gel

​Drug Facts

Purpose

Lidocaine 4% ………………………..Topical anesthetic

Menthol 1% …………………………Topical analgesic

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
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)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Glucosamine Sulfate, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Triethanolamine, Zemea (Corn) Propanediol

Lidocaine 4%   and Menthol 1 % Gel

NDC 50488-6641-1

120 grams

Manufactured for:

Alexso, Inc.

Los Angeles, CA 90064

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50488-6641-1

Lidocaine 4% + Menthol 1%

120 grams

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

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