Menthopatch
FDA Label NDC 72602-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Egyptian Saudi Co For Medical Manufacturing Mascomid for the product Menthopatch (NDC 72602-004). 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 active ingrdient, purpose, warnings, direction, dosage & administration, stop use and ask doctor, storage, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingrdient

Menthol 4% 

Capsicum  Extract  5 % 

Purpose

Temporarily relieves minor pain.

Warnings

  • For external use only
  • When using this product
  • Avoid contact with the eyes
  • Do not apply to wounds, or to damaged skin
  • Do not bandage tightly.
  • Consult doctor if pain continued after 7 days using product or excess skin inflamation.
  • Children under 12 years of age: consult doctor.

Direction

  • Clean and dry the affected area.
  • Open the cover of product and peel of the transparent layer of the product.
  • Paste the product on affected area.
  • Menthol patch is effective up to 8 hours which can replaced as needed.

Dosage & Administration

  • use menthol patch from 2 to 3 days

Stop Use And Ask Doctor

  • If condition worsens
  • If symptoms persist more than 7 days or clear up and occur again with a few days

Storage

  • Store in cool dry place avoid direct sunlight.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Inactive Ingredients

Glycerin 24 

Sodium poly acryl ate 8 
Aluminum chloride hexahydrate 
Citric acid 
Tartaric acid 
Polysorbate 80
Isopropyl myristate alcohol 2.5 
Car boxy methyl cellulose 
EDETA .2Na 0.5 
Polyvinyl pyrolidone(PVP-K90) 
Water 48
Titanium dioxide 
Methyl salicylate 
Camphor 
Hot act vbe 0.2
ACRYLATE/ C10-30 ALKYL ACRYLATE cross polymer

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