Active Ingredients Purpose
Menthol – 1.00% Pain Reliever
Pramoxine Hydrochloride – 1.00% External Analgesic
Medicated Anti-itch
FDA Label NDC 0363-3231
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Medicated Anti-itch (NDC 0363-3231). 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 ingredients purpose, stop use and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Stop Use And Ask A Doctor If
• condition worsens
• symptoms persisit more than 7 days or clear up and occur again within a few days
Directions
- Adults and children 2 years of age and older: apply to the affected area no more than 4 times daily
- Children under 2 years of age: consult a doctor
Other Information
Store at room temperature.
Inactive Ingredients
Water, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Leaf Juice, Sodium Acrylates Copolymer, Steareth-21, Mineral Oil,
Steareth-2, Tocopheryl Acetate, Thymol, Eucalyptol, Methyl Salicylate, PPG-1 Trideceth-6, Diazolidinyl Urea, Disodium EDTA, Triethanolamine,
Iodopropynyl Butylcarbamate
* Please review the disclaimer below.
