Active Ingredient
Menthol 0.44%
Zinc Oxide 20.625%
Proski Soothe
FDA Label NDC 84289-234
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmamed Usa Inc for the product Proski Soothe (NDC 84289-234). 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 ingredient, indication, use, warnings, do not use, when using this product, stop use and ask a doctor if, 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
Indication
External Analgesic
Skin Protectant
Use
A moisture barrier that prevents and helps heal skin irritations from:
• Urine • Diarrhea • Perspiration • Fistula drainage • Feeding tube site leakage • Wound drainage (peri-wound skin) • Minor burns • Cuts • Scrapes • Itching
Warnings
For external use only
Do Not Use
• On deep or puncture wounds
When Using This Product
• Avoid contact with eyes
Stop Use And Ask A Doctor If
• Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• Cleanse skin with mild skin cleanser.
• Pat dry or allow to air dry.
• Apply a thin layer of PROSKI SOOTHE to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long-lasting protection.
Other Information
• Store at room temperature 15°-30° C (59°-86° F)
• Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.
Inactive Ingredients
Ferric Oxide Red, Glycerin, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Petrolatum
Questions Or Comments?
(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)
Package/Label Principal Display Panel
NDC: 84289-234-01
CALAMINE SKIN PROTECTANT CREAM
Protects, Soothes
Enhanced Formula
Net Wt 4 oz. (113 g)
GOA/DRUGS/571
* Please review the disclaimer below.
