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| Product NDC Code | 69715-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Pedi-derm bum |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 204919 | ||||
| Application Number | M016 | ||||
| Labeler Name | Elixir Solutions, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide (CI 77947) 25%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Bismuth Subgallate, Gossypium Herbaceum (Cotton) Seed Oil, Lanolin, Zea Mays (Corn) Starch.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: Treats diaper rash and skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Pedi-Derm Bum Zinc Oxide ZINC OXIDE ZINC OXIDE BISMUTH SUBGALLATE LEVANT COTTONSEED OIL LANOLIN STARCH, CORN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel - Carton Label Letourneau’s Pharmacy Pedi-Derm Bum Paste™ Compounding Prescriptions Since 1926 Net WT 4oz (120g) Carton Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API