Active Ingredients
White petrolatum 75% w/w
Zinc oxide 20% w/w
Zinc Oxide 20% Ointment
FDA Label NDC 87236-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Zinc Oxide 20% (NDC 87236-020). 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, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
- temporarily protects minor cuts, scrapes, burns
- temporarily protects and helps relieve chapped or cracked skin
- helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
Warnings
For external use only
Do Not Use On
- deep or puncture wounds
- animal bites
- serious burns
When Using This Product
- do not get into eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last for more than 7 days or clear up and occur again within a few days
- you are allergic to any of these ingredients
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- for skin protection: apply as needed
- for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
- to open: unscrew cap, pull tab to remove foil seal
- store at 20° to 25°C (68° to 77°F)
- protect from freezing
- avoid excessive heat
- see carton or tube crimp for lot number and expiration date
Inactive Ingredient
mineral oil
Questions?
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