Menthol 5% Hydrogel Patch
FDA Label NDC 71391-127

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unexo Life Sciences, Private Limited for the product Menthol 5% Hydrogel (NDC 71391-127). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, when using this product, stop use and consult a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Manufactured in India By:
Unexo Life Sciences Pvt. Ltd.
B-16, Sector 4, Bawana Industrial Area,
Delhi - 110039 (INDIA)

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

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

Warnings

For external use only

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.

Otc - Pregnancy Or Breast Feeding

If pregnant of breastfeeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

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

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.

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

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*

    Principal Display Panel (5 Patch Pouch Carton)

    Principal Display Panel (5 Patch Pouch Carton)

* Please review the disclaimer below.