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| Product NDC Code | 66977-107 | ||||
|---|---|---|---|---|---|
| Drug Name | Regenecare ha |
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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 | 1011852, 2604879 |
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| Application Number | M017 | ||||
| Labeler Name | MPM Medical 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 Lidocaine HCl 2%
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 physician prior to use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe vera varvadensis leaf extract, Benzethonium chloride, Carbomer, Glycerin, Procollagen, Sodium hyaluronate, Triethanolamine, 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 the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.REGENECARE HA lidocaine HCl MARINE COLLAGEN, SOLUBLE ALOE VERA LEAF BENZETHONIUM CHLORIDE CARBOMER 940 GLYCERIN HYALURONATE SODIUM TROLAMINE WATER LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE
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 RegeneCare HA Gel
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
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature Avoid freezing and excessive heat
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 If swallowed, get medical help or contatct a Poison Control Center right away Avoid contact with the eyes If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult with a doctor Do not use in large quantities, particularly over raw surfaces or blistered areas Keep out of reach of children
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