Active Ingredient
Zinc Oxide (3.8%w/w)
Curetech Enshield
FDA Label NDC 73622-3066
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Curetech Skincare for the product Curetech Enshield (NDC 73622-3066). 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, 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
Skin Protectant
Uses
■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac
Warnings
For external use only
When Using This Product
■ do not get into eyes
Stop Use And Ask A Doctor If
conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed
Other Information
■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat
Inactive Ingredients
Aloevera Barbadensis Gel, Alpha Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl alcohol, Cholecalciferol, D&C Red No. 21, FD&C Yellow No.5, Glycerin, Lanolin, Lavender, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sodium Benzoate, Vitamin A (Palmitate), Water
* Please review the disclaimer below.
