Active Ingredient
Zinc Oxide 20%
Zinc Oxide 20%
FDA Label NDC 54162-040
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Zinc Oxide 20% (NDC 54162-040). 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, other, otc - stop use, keep out of reach of children., directions, for diaper rash:, 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.
- dries the oozing and weeping of, poison ivy, poison oak and poison sumac
Other
When using this product avoid contact with the eyes
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve within 7 days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a poison control center right away.
Directions
apply liberally as often as necessary
For Diaper Rash:
- 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 controlled room temperature 20°-25°C (68°-77°F).
Inactive Ingredients
mineral oil, petrolatum
Package Label.Principal Display Panel
28g Label (Geritrex Zincoxide 28g 5416204028)
56g Label (Geritrex Zincoxide 56g 5416204056)
454g Label (Geritrex Zincoxide 454g 5416204016)
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