Menthol And Camphor Cream

Menthol And Camphor Cream
SPL v2
SPL
SPL Set ID fbab708f-cec9-417a-aa12-905aa9f460cc
Route
TOPICAL
Published
Effective Date 2022-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Camphor (synthetic) (4 g)
Inactive Ingredients
Water Arnica Montana Flower Indian Frankincense Cetostearyl Alcohol Chondroitin Sulfate (bovine) Glucosamine Sulfate Glycerin Glyceryl Caprylate Glyceryl Monostearate C13-14 Isoparaffin Isopropyl Alcohol Isostearyl Palmitate Laureth-7 Dimethyl Sulfone Peg-100 Stearate Phenoxyethanol Polyacrylamide (10000 Mw) Propylene Glycol Sodium Polyacrylate (8000 Mw) Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-09-01

Description

Menthol 10% and Camphor 4% Cream Alexso, Inc ---------- Menthol 10% and Camphor 4% Cream  ​Drug Facts

Purpose

Menthol 10% ……………………………………..………………….…Topical analgesic Camphor 4% ……………………………………………………………Topical analgesic


Medication Information

Purpose

Menthol 10% ……………………………………..………………….…Topical analgesic

Camphor 4% ……………………………………………………………Topical analgesic

Description

Menthol 10% and Camphor 4% Cream Alexso, Inc ---------- Menthol 10% and Camphor 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 10% and Camphor 4% Cream

Alexso, Inc

----------

Menthol 10% and Camphor 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

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, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, 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 10% and Camphor 4% Cream

NDC: 50488-0410-1

120 grams

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

Principal Display Panel

NDC 50488-0410-1

Menthol 10% + 

Camphor 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 10% and Camphor 4% Cream

Alexso, Inc

----------

Menthol 10% and Camphor 4% Cream 

​Drug Facts

Purpose

Menthol 10% ……………………………………..………………….…Topical analgesic

Camphor 4% ……………………………………………………………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

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, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, 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 10% and Camphor 4% Cream

NDC: 50488-0410-1

120 grams

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50488-0410-1

Menthol 10% + 

Camphor 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.


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