Menthozen Cream

Menthozen Cream
SPL v6
SPL
SPL Set ID 2adf3c4d-636f-4e02-b501-946b4df5f5d6
Route
TOPICAL
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (200 mg) Menthol (50 mg) Capsaicin (0.375 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Flower Cetyl Alcohol Dmdm Hydantoin Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glyceryl Monostearate Ilex Paraguariensis Leaf Dimethyl Sulfone Peg-100 Stearate Phenoxyethanol Polysorbate 20 Stearic Acid Stearyl Alcohol Trolamine Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-01

Description

Methyl Salicylate 20.00% Menthol 5.00% Capsaicin 0.0375%


Medication Information

Description

Methyl Salicylate 20.00% Menthol 5.00% Capsaicin 0.0375%

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Section 55105-1

Topical Analgesic

Warnings:
  • For external use only.
  • Avoid contact with the eyes.
  • If condition worsens, or if symptoms persist for more than seven days or clear up and occur again with a few days, discontinue use of this product and consult a physician.
Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Do Not Apply
  • to wounds or damaged skin.
  • Do not bandage tightly.
Package Labeling:
Other Information:

Store at room temperature.

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Active Ingredients:

Methyl Salicylate 20.00%

Menthol 5.00%

Capsaicin 0.0375%

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, DMDM Hydantoin, Emulsifying Wax, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate’) Extract, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum, Zemea (Corn) Propanediol.

If Pregnant Or Breast Feeding,

contact a physician prior to use.

Keep Out of Reach of Children.

If swallowed, consult physician.


Structured Label Content

Uses: (USES:)

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Section 55105-1 (55105-1)

Topical Analgesic

Warnings: (WARNINGS:)
  • For external use only.
  • Avoid contact with the eyes.
  • If condition worsens, or if symptoms persist for more than seven days or clear up and occur again with a few days, discontinue use of this product and consult a physician.
Directions: (DIRECTIONS:)

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Do Not Apply (Do not apply)
  • to wounds or damaged skin.
  • Do not bandage tightly.
Package Labeling:
Other Information: (OTHER INFORMATION:)

Store at room temperature.

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Active Ingredients: (ACTIVE INGREDIENTS:)

Methyl Salicylate 20.00%

Menthol 5.00%

Capsaicin 0.0375%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, DMDM Hydantoin, Emulsifying Wax, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate’) Extract, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum, Zemea (Corn) Propanediol.

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

contact a physician prior to use.

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

If swallowed, consult physician.


Advanced Ingredient Data


Raw Label Data

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