Active Ingredient
Zinc Oxide 14%
Diaper Rash Cream
FDA Label NDC 82057-579
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ellaola Brands Inc. for the product Diaper Rash Cream (NDC 82057-579). 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, warnings, purpose, inactive ingredients, uses, directions, other information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose
Skin Protectant
Inactive Ingredients
Beeswax, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Helianthus Annuus (Sunflower) Seed Oil, Laminaria Ochroleuca Extract, Polyglyceryl-2 Dipolyhydroxystearate, Ricinus Communis (Castor) Seed Oil
Uses
Helps treat and prevent diaper rash
Protects chafed skin due to diaper rash
Helps seal out wellness
Directions
Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers may be prolonged.
Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers maybe be prolonged.
Other Information
Store at room tempreature and protect this product from direct sunlight.
Package Label.Principal Display Panel
EllaOla Diaper Cream Tube 88mL NDC: 82057-579-01
EllaOla Diaper Cream Carton NDC: 82057-579-02
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