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| Product NDC Code | 54312-525 | ||||
|---|---|---|---|---|---|
| Drug Name | Vitacilina bebe diaper rash |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1441179 | ||||
| Application Number | M016 | ||||
| Labeler Name | Compania Internacional de Comercio, S.A.P.I de C.V. | ||||
| 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 ingredients Allantoin 1% Zinc Oxide 25% Purpose Skin Protectant
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 Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply ointment as often as necesary with each diaper change, especially at bedtime or anytime when exposure to wet diapers maybe prolonged.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Petrolatum, corn starch, fragrance, lanolin, methylparaben, mineral oil, propylparaben, vitamin A (palmitate), vitamin D (calciferol), vitamin E (tocopherol).
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 and prevents diaper rash • Protects minor skin irritation associated with diaper rash • Helps seal out wetness
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.VITACILINA Bebe Diaper Rash ALLANTOIN, ZINC OXIDE PETROLATUM STARCH, CORN LANOLIN METHYLPARABEN MINERAL OIL PROPYLPARABEN VITAMIN A VITAMIN D .ALPHA.-TOCOPHEROL ALLANTOIN ALLANTOIN ZINC OXIDE ZINC CATION
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.Package Labeling: Outer Package5 Outer Package6 Inner Package5
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 the reach of children
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 Avoid contact with the eyes If condition worsens or does not improve within 7 days, consult a doctor Keep out of the reach of children
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