Active Ingredient
Zinc Oxide 20%
Proski Zinco Skin Protectant
FDA Label NDC 84289-119
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 Zinco Skin Protectant (NDC 84289-119). 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, purpose, use, 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
Skin Protectant
Use
Helps treat chafed skin associated with diaper rash
Dries the oozing and weeping of poison: • ivy • oak •sumac
Warnings
For External Use Only.
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
• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area,
and allow to dry.
• Apply ointment liberally as often as necessary with each diaper
change, especially at bedtime or anytime when exposure to wet diapers may be
prolonged.
• For poison ivy, oak, and sumac: 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 seal is damaged.
Inactive Ingredients
CETETH-20, CETOSTEARYL ALCOHOL, LIGHT MINERAL OIL, WHITE PETROLATUM
Questions Or Comments?
(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)
Package/Label Principal Display Panel
NDC: 84289-119-20
ZINC OXIDE OINTMENT
Skin Protectant
Net Wt 1 oz. (28.4 g)
GOA/DRUGS/571
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