Active Ingredient
Zinc Oxide 20%
Endit Zinc Oxide Skin Protection Ointment
FDA Label NDC 64068-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Endit Laboratories, Inc. for the product Endit Zinc Oxide Skin Protection (NDC 64068-500). 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 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 rash associated with diaper use, incontinence, or exposure to feces and urin, Protects chafed skin due to diaper rash and helps seal out wetness.
Warnings
For external use only.
When Using This Product
do not get in 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 right away.
Directions
For treatment of diaper rash:
- Change wet and soiled diapers promptly.
- Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry.
- Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled diapers (feces, and/or urine) may be prolonged.
Inactive Ingredients
Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol, White Petrolatum
Package Labeling:56.7 G
Label (Label)
Package Labeling:113.4 G
Label2 (Label2)
Package Labeling:227G
Label3 (Label3)
* Please review the disclaimer below.
