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Product NDC Code | 61924-174 | ||||||||
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Drug Name | Dermacerin |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | OINTMENT | ||||||||
Application Number | M016 | ||||||||
Labeler Name | DermaRite Industries, LLC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Petrolatum 33%
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 as needed or as directed by a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Water, Mineral Oil, Paraffin, Lanolin Alcohol, PEG-30 Dipolhydroxystearate, DMDM Hydantoin, Methylparaben, Propylparaben, Propylene Glycol, Sodium Chloride
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: Temporarily protects and helps relieve dry, chapped, or cracked skin. Helps protect skin from the drying effects of wind and cold weather.
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.DermaCerin Skin Protectant PARAFFIN PROPYLENE GLYCOL 2-(2-METHYLBUTYRATE) WATER PETROLATUM PETROLATUM SODIUM CHLORIDE PROPYLPARABEN LANOLIN ALCOHOLS MINERAL OIL DMDM HYDANTOIN METHYLPARABEN PEG-30 DIPOLYHYDROXYSTEARATE
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.DermaCerin Package Label and Principal Display Panel Package Label Carton Label Package Label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Warnings: Stop and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Warnings: Do not use on deep or puncture wounds, animal bites, or serious wounds.
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.Warnings: Keep out of reach of children. In case of accidental ingestion contact a Physician or 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: Store at room temperature (59º- 86ºF) You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 800-337-6296 Mon - Fri 9AM - 5PM EST.
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 eyes. In case of contact, flush thoroughly with water
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