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| Product NDC Code | 58980-913 | ||||
|---|---|---|---|---|---|
| Drug Name | Peviderm pramoxine hydrocholride 1% |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M017 | ||||
| Labeler Name | Stratus Pharmaceuticals 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 Hydrochloride 1%
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 to open, hold cap tightly and turn pump counter-clockwise 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 Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Isopropyl Myristate, Petrolatum, PEG-8 Stearate, PEG-100 Stearate, Purified Water, Sodium Hydroxide, Stearic Acid.
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 for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac
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.Peviderm Pramoxine Hydrocholride 1% Pramoxine Hydrochloride Pramoxine Hydrochloride PRAMOXINE Water Glyceryl Stearate/PEG-100 Stearate PEG-8 Stearate Calcium Chloride CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) Cetyl Palmitate Isopropyl Myristate White Petrolatum Stearic Acid Benzyl Alcohol Sodium Hydroxide
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 - 222 mL Bottle Box NDC 58980-913-80 Steroid-Free & Fragrance-Free PEVIDERM™ PRAMOXINE HYDROCHLORIDE 1% ITCH RELIEF FOR SENSITIVE SKIN EXTERNAL ANALGESIC LOTION Moisturizes and gently relieves itch associated with: Eczema and Dry Sensitive Skin Net 7.5 fl oz (222 mL) PRINCIPAL DISPLAY PANEL - 222 mL Bottle Box
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
Distributed by: STRATUS PHARMACEUTICALS INC Miami, Florida 33186
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 immediately
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call us at 1-800-442-7882
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 condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]
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 When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately
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