Otc - Active Ingredient
Active Ingredient
Zinc Oxide 13%
Budpak Diaper Rash
FDA Label NDC 27293-028
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Budpak Inc. for the product Budpak Diaper Rash (NDC 27293-028). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Skin Protectant
Indications & Usage
Uses
Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash. Helps seal out wetness
Warnings
Warnings
For external use only
Otc - When Using
When using this product do not get into eyes
Otc - Stop Use
Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again in few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact Poison Control Center right away.
Dosage & Administration
Directions
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, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.
Other
Other Information
Store at 20°to 25°C (68° to 77°F).
PRINCIPAL DISPLAY PANEL
Budpak Diaper Rash Cream
Zinc Oxide 13%
NET WT 1 OZ (28 g)
Inactive Ingredient
Inactive Ingredients
Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Magnesium Sulfate, Phenoxyethanol, Methylparaben, Fragrance, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.
Package Label.Principal Display Panel
Image Of Package Label (Diaper Rash Cream)
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