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Product NDC Code | 24330-130 | ||||
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Drug Name | First degree maximum strength burn |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 1052684 | ||||
Application Number | part348 | ||||
Labeler Name | Welmedix 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 Pramoxine HCL 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 adults and children 2 years of age and older: clean the affected area apply to affected area not more than 3 to 4 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients butyrospermum parkii (shea butter), C18-22 hydroxyalkyl hydroxypropyl guar, calendula officinalis extract, cantharis vesicatoria extract, echinacea angustifolia extract, ethyl alcohol, hydrogenated polydecene, isopropyl myristate, lanolin, lanolin alcohol, petrolatum, phenoxyethanol, water, sodium hydroxide, sodium polyacryloyldimethyl taurate, trideceth-10
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 insect bites sunburns minor cuts scrapes 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.First Degree Maximum Strength Burn Pramoxine Hydrochloride Pramoxine Hydrochloride Pramoxine SHEA BUTTER CALENDULA OFFICINALIS FLOWERING TOP LYTTA VESICATORIA GUAR GUM ECHINACEA ANGUSTIFOLIA ALCOHOL HYDROGENATED POLYDECENE (550 MW) ISOPROPYL MYRISTATE LANOLIN LANOLIN ALCOHOLS PETROLATUM PHENOXYETHANOL WATER SODIUM HYDROXIDE SODIUM TAURATE TRIDECETH-10
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 - 21 g Tube Box NEW & IMPROVED! First° Degree ® MAXIMUM STRENGTH BURN CREAM PRAMOXINE HCL 1% PAIN RELIEVING CREAM FAST RELIEF FOR PAIN + ITCH GREAT FOR MINOR BURNS BUG BITES HELPS REDUCE THE APPEARANCE OF SCARS ENRICHED WITH NOURISHING BOTANICALS 1 Tube Net Wt 3/4 oz (21 g) Principal Display Panel - 21 g Tube 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: Welmedix Consumer Healthcare Princeton, NJ 08540
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.Do not use if you are allergic to any of the ingredients over large areas of the body
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 a Poison Control Center right away.
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? 1-888-565-2876 Monday through Friday, 9am-5pm EST
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 1 week, or clear up and occur again within a few days rash or other allergic reaction develops
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20-25°C (68-77°F)
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 Do not use if you are allergic to any of the ingredients over large areas of the body Stop use and ask a doctor if condition worsens symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control 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