Active Ingredient
Zinc Oxide 20%
Medpura Zinc Oxide 20% Ointment
FDA Label NDC 71399-0245
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Medpura Zinc Oxide 20% (NDC 71399-0245). 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
- protects chafed skin due to diaper rash and helps seal out wetness
- protects and dries the oozing and weeping of poison ivy, poison oak, and poison sumac.
Warnings
For External Use Only
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor If
if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- change wet or soiled diapers promptly
- cleanse the diaper area and allow to dry
- apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Other Information
- store at room temperature 20˚-25˚C (68˚-77˚F)
- may stain clothing
Inactive Ingredients
alovera gel, mineral oil, white petrolatum
Questions And Comments?
Call toll-free 1-877-225-6999
Package Label.Principal Display Panel
16oz (16oz)
3oz (3ozcrt)
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