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| Product NDC Code | 0496-0586 | ||||
|---|---|---|---|---|---|
| Drug Name | Dermend moisturizing anti-itch |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 1246075 | ||||
| Application Number | part348 | ||||
| Labeler Name | Ferndale Laboratories, 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 Pramoxine HCl 1% w/w
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 adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cetyl alcohol, di-isopropyl adipate, dimethicone, glycerin, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), mineral oil, polyoxyl 40 stearate, potassium sorbate, povidone, purified water, sorbic acid, stearic acid, and trolamine
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.Use for the temporary relief of itching associated with minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose external analgesic
Spl product data elements
Usually a list of ingredients in a drug product.DerMend Moisturizing Anti-Itch pramoxine hydrochloride CETYL ALCOHOL DIISOPROPYL ADIPATE DIMETHICONE GLYCERIN PETROLATUM LANOLIN HYDROGENATED COCONUT OIL SORBITAN SESQUIOLEATE STEARYL ALCOHOL MINERAL OIL POLYOXYL 40 STEARATE POTASSIUM SORBATE POVIDONE WATER SORBIC ACID STEARIC ACID TROLAMINE PRAMOXINE HYDROCHLORIDE PRAMOXINE
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 Label NDC 0496-0586-08 8oz (237mL) DerMendBottleLabel
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, seek medical attention or contact a Poison Cotrol Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again within a few days
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. Stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Cotrol 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