Active Ingredients
Zinc Oxide 2%
Dimethicone 1.8%
Proski Shield
FDA Label NDC 84289-408
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 Shield (NDC 84289-408). 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, uses, warnings, when using this product:, stop use and ask a doctor if:, keep out of reach of children:, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
- Diaper rash
- Skin Protectant
Uses
- Use as a general skin protectant
- Helps treat chafed skin associated with diaper & nappy rash
Warnings
For External Use Only.
When Using This Product:
- Avoid contact with eyes
- Do not use over large areas of the body
- So not use if you are alergic to any of the ingredients
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
- For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
- For other uses: Apply as needed.
Other Information
- Store at room temperature between 15° - 30°C (59° - 86°F)
- Avoid excessive heat
- Tamper evident. Do not use if the seal is damaged.
Inactive Ingredients
Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), CETETH-20, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Yellow 5, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Petrolatum
Questions And Comments?
(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)
Package/Label Principal Display Panel
NDC: 84289-408-02
DIMETHICONE SKIN PROTECTANT BARRIER CREAM WITH
■ Vitamin A ■ Vitamin D ■ Vitamin E ■ Zinc Oxide ■ Aloe Vera
Enhanced Formula
Net Wt 4 oz. (113 g)
GOA/DRUGS/571
* Please review the disclaimer below.
