FDA Label for Pedi-derm Bum
View Indications, Usage & Precautions
Pedi-derm Bum Product Label
The following document was submitted to the FDA by the labeler of this product Elixir Solutions, 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.
Active Ingredient
Zinc Oxide (CI 77947) 25%
Purpose
Skin Protectant
Uses:
Treats diaper rash and skin irritations
Warnings
For external use only. Do not use in the eyes or if you allergic to any of the ingredients. Stop use and ask a doctor if you need to use longer than 1 week or condition worsens.
Keep Out Of Reach Of Children.
If swallowed get medical help or contact Poison Control Center right away.
Directions:
Apply a thick coat after diaper change, especially at bedtime. If baby cries during application it is because of their sensitive skin, this product does not sting. Use soft cloth or paper towel to clean bottom.
Other Information:
Do not store in conditions of excess humidity or heat beyond 42°C (107°F).
Do not use if seal under cap is missing or broken.
Inactive Ingredients:
Bismuth Subgallate, Gossypium Herbaceum (Cotton) Seed Oil, Lanolin, Zea Mays (Corn) Starch.
Principal Display Panel - Carton Label
Letourneau’s Pharmacy
Pedi-Derm Bum Paste™
Compounding Prescriptions Since 1926
Net WT
4oz (120g)
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