FDA Label for Budpak Diaper Rash

View Indications, Usage & Precautions

Budpak Diaper Rash Product Label

The following document was submitted to the FDA by the labeler of this product Budpak Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient

Zinc Oxide 13%


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




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