Menthol 5% Hydrogel Patch

Menthol 5% Hydrogel Patch
SPL v3
SPL
SPL Set ID 3f6feec5-2019-4fe6-b2b9-fd1c04d9a1f1
Route
TOPICAL
Published
Effective Date 2025-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (600 mg)
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Alcohol Carboxymethylcellulose Sodium, Unspecified Edetate Disodium Dihydroxyaluminum Aminoacetate Glycerin Kaolin Methylparaben Polysorbate 80 Polyvinyl Alcohol, Unspecified Propylparaben Povidone, Unspecified Sodium Polyacrylate (2500000 Mw) Sorbitan Monooleate Sorbitol Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

Drug Facts

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Drug Facts

Use

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps

Section 42229-5

Drug Facts

Section 50565-1

Keep Out of Reach of Children. Do not use on infants. If swallowed, seek medical help or contact a Poison Control Centre right away.

Section 53414-9

If pregnant of breastfeeding, ask a health professional before use

Warnings

For external use only

Directions
  • Adults and children 12 years of age and over: Carefully remove backing from patch. Applu sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age consult a physician.
Active Ingredient

Menthol 5%

Other Information

Store at room temperature below 86°F (30°C)

Inactive Ingredients

acrylates copolymer, alcohol, carboxymethylcellulose sodium, edetate Disodium, dihydroxyaluminium aminoacetate, glycerine, kaolin, methylparaben, polysorbate 80, polyvinyl alcohol, propylparaben, PVP, sodium polyacrylate, sorbitan oleate, sorbitol, tartaric Acid, titanium Dioxide, water

When Using This Product
  • Use only as directed
  • Rare cases of serious burns have been reported with products of this type
  • Don't bandage tightly or use with a heating pad
  • Avoid contact with eyes or mucous membranes
  • Don't apply to wounds or damaged skin
  • Do not use at the same time as other topical analgesics
Stop Use and Consult A Doctor If
  • Condition worsens
  • redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury such as pain, swelling, or blistering where the product was applied.
Principal Display Panel 5 Patch Pouch Carton

NDC 71391-127-05

UNEXO'S MENTHOL 5%

HYDROGEL PATCH

5% Menthol

BACK & LARGE AREAS

Targeted, Long-Lasting

Pain Relief

TOPICAL ANALGESIC

  • Adhesive Fabric Patch
  • No-Mess Application
  • Single Use

5

PATCHES

7.87 IN. X 3.93 IN. (20 cm × 10 cm)

Compare to Extra Strength

Icy Hot® Medicated Patch

active ingredient*


Structured Label Content

Use

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep Out of Reach of Children. Do not use on infants. If swallowed, seek medical help or contact a Poison Control Centre right away.

Section 53414-9 (53414-9)

If pregnant of breastfeeding, ask a health professional before use

Purpose

Topical Analgesic

Warnings

For external use only

Directions
  • Adults and children 12 years of age and over: Carefully remove backing from patch. Applu sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age consult a physician.
Active Ingredient

Menthol 5%

Other Information

Store at room temperature below 86°F (30°C)

Inactive Ingredients

acrylates copolymer, alcohol, carboxymethylcellulose sodium, edetate Disodium, dihydroxyaluminium aminoacetate, glycerine, kaolin, methylparaben, polysorbate 80, polyvinyl alcohol, propylparaben, PVP, sodium polyacrylate, sorbitan oleate, sorbitol, tartaric Acid, titanium Dioxide, water

When Using This Product (When using this product)
  • Use only as directed
  • Rare cases of serious burns have been reported with products of this type
  • Don't bandage tightly or use with a heating pad
  • Avoid contact with eyes or mucous membranes
  • Don't apply to wounds or damaged skin
  • Do not use at the same time as other topical analgesics
Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • Condition worsens
  • redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury such as pain, swelling, or blistering where the product was applied.
Principal Display Panel 5 Patch Pouch Carton (PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Carton)

NDC 71391-127-05

UNEXO'S MENTHOL 5%

HYDROGEL PATCH

5% Menthol

BACK & LARGE AREAS

Targeted, Long-Lasting

Pain Relief

TOPICAL ANALGESIC

  • Adhesive Fabric Patch
  • No-Mess Application
  • Single Use

5

PATCHES

7.87 IN. X 3.93 IN. (20 cm × 10 cm)

Compare to Extra Strength

Icy Hot® Medicated Patch

active ingredient*


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)