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| Product NDC Code | 77338-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Astonea burn cream |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1012100 | ||||
| Application Number | part348 | ||||
| Labeler Name | ASTONEA LABS PRIVATE LIMITED | ||||
| 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 Ingredients Lidocaine HCL 0.5% Topical Analgesic Benzalkonium Chloride 0.13% Topical Antiseptic
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 and over: clean the affected area apply a small amount of this product on the area 3 or 4 times daily. may be covered with a sterile bandage Children under 2 years consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, Purified water, Stearic acid, Triethanolamine.
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 temporary relief of pain and itching associated with: Sunburn Minor burns, Insect bites, Minor skin irritation, Cuts Scrapes
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic Topical Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.ASTONEA Burn Cream Lidocaine ALOE VERA LEAF CETOSTEARYL ALCOHOL EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN GLYCERYL STEARATE/PEG-100 STEARATE MALTODEXTRIN PHENOXYETHANOL GLYCERIN WATER MINERAL OIL PROPYLENE GLYCOL STEARIC ACID TROLAMINE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS BENZALKONIUM CHLORIDE BENZALKONIUM
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 Principal Display and Drug Fact Panel
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.Other Information •store in a cool, dry area 59°-86°F (15°-30°C) •tamper evident sealed packets do not use any opened or torn packets
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 Do Not Use: In the eyes Over large areas of the body or on deep puncture wounds, animal bites or serious burns. In large quantities, particularly over raw surfaces or blistered areas.
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.
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 •the condition gets worse •condition clears up and recurs within a few days •condition persists for more than 7 days
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding ask a health care professional before use.
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
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