Active Ingredient
Zinc Oxide 40%
Diaper Rash Cream 2oz Cream
FDA Label NDC 57337-164
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International Corp. for the product Diaper Rash Cream 2oz (NDC 57337-164). 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, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Use
- helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
Warnings
Warnings: For external use only.
When Using This Product
When using this product do not get into eyes.
Stop Use And Ask A Doctor If
- condition worsens
- symtoms 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.
Do Not Use
Do not use if tube seal under cap is broken or missing
Directions
- change wet and soiled diapers promotly
- cleanse the diaper area
- allow to dry
- apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers will be prolonged
Other Information
- store at 68° to 77°F (20° to 25°C)
- do not use if tube seal under cap is broken or missing
Inactive Ingredients
Petrolatum, Mineral Oil, Lanolin, Isopropyl Myristate, Beeswax, Tocopheryl Acetate, Cod Liver Oil, Aloe Barbadensis Leaf Juice
Label
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