Menthol Cream

Menthol Cream
SPL v2
SPL
SPL Set ID ebfd4e87-3dd4-4db0-a26b-3a11a9811886
Route
TOPICAL
Published
Effective Date 2019-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Water Arnica Montana Flower Indian Frankincense Cetostearyl Alcohol Ethylhexylglycerin Glucosamine Sulfate Glycerin Glyceryl Monostearate C13-14 Isoparaffin Isopropyl Alcohol Isostearyl Palmitate Laureth-7 Dimethyl Sulfone Peg-100 Stearate Phenoxyethanol Propylene Glycol Stearic Acid Trolamine Chondroitin Sulfate (bovine) Sodium Polyacrylate (8000 Mw) Polyacrylamide (10000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-04-01

Description

Menthol 4 % Cream Alexso, Inc ---------- Menthol 4 % Cream   ​Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 4 % Cream Alexso, Inc ---------- Menthol 4 % Cream   ​Drug Facts

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Section 42229-5

Menthol 4 % Cream

Alexso, Inc

----------

Menthol 4 % Cream  

​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  ask a doctor
Active Ingredient

Menthol 4%

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

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Alcohol, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

Menthol 4% Cream

NDC: 50488-1040-1

120 grams

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

Principal Display Panel

NDC 50488-1040-1

Menthol 4% Cream

120 grams

When Using This Product
  • Avoid contact with 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

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Section 42229-5 (42229-5)

Menthol 4 % Cream

Alexso, Inc

----------

Menthol 4 % Cream  

​Drug Facts

Purpose

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  ask a doctor
Active Ingredient (Active ingredient)

Menthol 4%

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)

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Alcohol, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

Menthol 4% Cream

NDC: 50488-1040-1

120 grams

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50488-1040-1

Menthol 4% Cream

120 grams

When Using This Product (When using this product)
  • Avoid contact with 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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