Menthozen Hydrogel Patch

Menthozen Hydrogel Patch
SPL v6
SPL
SPL Set ID 85a7809e-c43f-4138-a85b-44e1b586def5
Route
TOPICAL
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg) Capsaicin (0.3 mg)
Inactive Ingredients
Water Glycerin Carboxymethylcellulose Sodium, Unspecified Polysorbate 80 Lemon Oil, Cold Pressed Dihydroxyaluminum Aminoacetate Anhydrous Methylparaben Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-01
Description

Menthol 4.00% Capsaician 0.03%

Medication Information

Description

Menthol 4.00% Capsaician 0.03%

Uses:

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

Section 55105-1

External Analgesic

Warnings:

For external use only. Use only as directed.

  • •
    Avoid contact with eyes and mucous membranes.
  • •
    Do not apply to open wounds or damaged skin.
Do Not Use
  • •
    in combination with any external heat source.
  • •
    Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
Directions:

Adults and children 12-years and over: Apply to affected area; change patch 1-2 times dily.

Children under 12, consult a physician before use.

How to Apply:

Remove patch from backing and apply directly to area of pain.

Do not apply to affected area more than three times daily.

Use only one patch at a time.

Wash hands with soap and water immediately after application.

Reseal pouch containg unused patches. 

Package Labeling:

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Other Information:

Store below 25 degrees Celsius. Avoid direct sunlight.

Active Ingredients:

Menthol 4.00%

Capsaician 0.03%

Inactive Ingredients:

Aqua (Deionized Water), Sodium Polyacrylate, Glycerol, D-Glucitrol, Sodium Cellulose Glycolate, Polysorbate-80, Lemon Oil, Aluminum Glycinate, Methylparaben, EDTA Disodium Salt

If Pregnant Or Breast Feeding,
  • •
    contact physician prior to use
Keep Out of Reach of Children.
  • •
    Do not use if allergic to Menthol.
Stop Use and Consult Physician
  • •
    if symptoms worsen or persist for more than 7 days.
  • •
    Stop use if itching or excessive skin irritation occurs.

Structured Label Content

Uses: (USES:)

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

Section 55105-1 (55105-1)

External Analgesic

Warnings: (WARNINGS:)

For external use only. Use only as directed.

  • •
    Avoid contact with eyes and mucous membranes.
  • •
    Do not apply to open wounds or damaged skin.
Do Not Use (Do not use)
  • •
    in combination with any external heat source.
  • •
    Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
Directions: (DIRECTIONS:)

Adults and children 12-years and over: Apply to affected area; change patch 1-2 times dily.

Children under 12, consult a physician before use.

How to Apply:

Remove patch from backing and apply directly to area of pain.

Do not apply to affected area more than three times daily.

Use only one patch at a time.

Wash hands with soap and water immediately after application.

Reseal pouch containg unused patches. 

Package Labeling:

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Other Information: (OTHER INFORMATION:)

Store below 25 degrees Celsius. Avoid direct sunlight.

Active Ingredients: (ACTIVE INGREDIENTS:)

Menthol 4.00%

Capsaician 0.03%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aqua (Deionized Water), Sodium Polyacrylate, Glycerol, D-Glucitrol, Sodium Cellulose Glycolate, Polysorbate-80, Lemon Oil, Aluminum Glycinate, Methylparaben, EDTA Disodium Salt

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)
  • •
    contact physician prior to use
Keep Out of Reach of Children. (Keep out of reach of children.)
  • •
    Do not use if allergic to Menthol.
Stop Use and Consult Physician (Stop use and consult physician)
  • •
    if symptoms worsen or persist for more than 7 days.
  • •
    Stop use if itching or excessive skin irritation occurs.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:27.719850 · Updated: 2026-03-14T23:02:00.533418