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| Product NDC Code | 80551-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Burn relief aloe |
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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 | GEL | ||||
| RxCUI drug identifier | 1010077 | ||||
| Application Number | M017 | ||||
| Labeler Name | Acutens | ||||
| 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 Purpose LIDOCAINE HYDROCHLORIDE Pain Reliever
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.Direction adults and children over 2 years and older : • Apply to affected area not more than 3-4 times a day • Children under 2 years old: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Extract Avena Sativa (Oat) Kernel Extract Blue 1 Caprylyl Glycol Chlorphenesin Dimethyl Isosorbide Glycerin Hydroxyethylcellulose Isopropyl Alcohol Phenoxyethanol Polysorbate 20 Propanediol Tocopheryl Acetate Water
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 due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation
Spl product data elements
Usually a list of ingredients in a drug product.Burn Relief Aloe Lidocaine HCl ALOE OAT CAPRYLYL GLYCOL CHLORPHENESIN DIMETHYL ISOSORBIDE GLYCERIN CETYL HYDROXYETHYLCELLULOSE (350000 MW) ISOPROPYL ALCOHOL PHENOXYETHANOL POLYSORBATE 20 PROPANEDIOL .ALPHA.-TOCOPHEROL ACETATE WATER LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE
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.image description
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.
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. Rinse with water if contact occurs. Stop use and ask doctor if • symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use in large quantities, particularly over raw surfaces or blistered area
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