Active Ingredients
Zinc Oxide
Petrolatum
Shield And Protect Barrier Cream
FDA Label NDC 61554-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gentell Llc for the product Shield And Protect Barrier Cream (NDC 61554-500). 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, keep out of rach of children, inactive ingredients, purpose, warnings, dosage & administration, indication and usage, primary label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Keep Out Of Rach Of Children
Keep out of reach of Children
Inactive Ingredients
Purified water
Mineral oil
Sodium Chloride
Castor wax
Bees wax
Imidazolidinyl Urea
Propylparaben
Methylparaben
Vitamin A Palmitate
Cetostearyl alcohol
Vitamin D 3
Purpose
Gentell Shield & Protect Moisture Barrier Cream forms a water-shedding shield thta helps soothe and protect dry or irritated skin. Theraprutic against irritation from urine, feces, and other bodily secretions. Sheild & Protect leaves skin soft and smooth rather than irretated and greasy. Ideal for sensitive skin.
Warnings
For external use only
Avoid eye contact
Discontinue use and contact a physiciean if condition worsens, or symptoms persist from more than seven days
Keep this out of the reah of children
Dosage & Administration
Carefully cleanse the area and pat dry thoroughly. Apply liberally to desired areas as often as necessary or when prolonged wxposure is anticipated.
Indication And Usage
Shield & Protect Moisture Barrier Cream helps restore, replenish and soothe ry irritated or otherwise compromised skin.
It helps treat or pevent minor skin irritations assoiated with incontinence.
Protects fom and seals out wetness
* Please review the disclaimer below.
