FDA Label for Proski Soothe
View Indications, Usage & Precautions
Proski Soothe Product Label
The following document was submitted to the FDA by the labeler of this product Pharmamed Usa Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Menthol 0.44%
Zinc Oxide 20.625%
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.
