Active Ingredient
Zinc oxide 40%
Zinc Oxide 40%
FDA Label NDC 50157-477
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Brands International for the product Zinc Oxide 40% (NDC 50157-477). 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, otc - 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
Warnings
For external use only
When Using This Product
do not get into 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
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- change wet and soiled diapers promptly
- cleanse the diaper area
- allow to dry
- apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
- See box for more details
Inactive Ingredients
Sunflower oil, Castor Oil, Sunflower seed wax, polyhydroxystearic acid, shea butter, coconut oil, theobroma cacao seed butter, calophyllum seed oil, tocopherol, zea mays corn starch
Questions And Comments?
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Label
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