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| Product NDC Code | 51822-021 | ||||
|---|---|---|---|---|---|
| Drug Name | Petrocort antipruritic lip 21 |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIPSTICK | ||||
| RxCUI drug identifier | 310861 | ||||
| Application Number | M017 | ||||
| Labeler Name | Clinical Formula LLC | ||||
| 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 (in percentage) Hydrocortisone 0.5% Purpose For relief of minor skin irritation.
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 to lips 1-3 times daily or use as directed by physician. For use on children under 5 years of age, consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Petrolatum, Syncrowax HGL-C, Syncorwax ERL-C, Padimate-O Mineral Oil, Propylparaben, Fragrance, FD & C Yellow # 5, FD & C Blue # 1.
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: Adults and children 5 years and over: For the temporary relief of minor skin irritations and rashes. Help prevent and temporarily protect chafed, chapped, cracked, windburned or sunburned lips.
Purpose
Information about the drug product’s indications for use.Purpose For relief of minor skin irritation.
Spl product data elements
Usually a list of ingredients in a drug product.Petrocort Antipruritic Lip 21 HYDROCORTISONE PETROLATUM C18-36 ACID TRIGLYCERIDE PADIMATE O MINERAL OIL PROPYLPARABEN FD&C YELLOW NO. 5 FD&C BLUE NO. 1 HYDROCORTISONE HYDROCORTISONE
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: Label
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 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. If condition worsens, does not improve, or symptoms persist for more than 7 days or clear up and reoccur again within a few days, discontinue use and consult a physician. Keep from heat. Keep out of 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