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| Product NDC Code | 49947-002 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hush anesthetic |
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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 | 1291672 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | HUSH Anesthetic | ||||||
| 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 4% w/w
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 or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age; consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Calendula Officinale Extract, Caprylyl Glycol, Chamomile (Chamomile Recutita) Extract, Comfrey (Symphytum Officinale) Extract, Disodium EDTA, Glycerin, Green Tea (Camellia Sinensis) Extract, Menthol, Methylisothiazolinone, Propylene Glycol, SD Alcohol 40B, 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 the temporary relief of pain and itching associated with minor cuts or minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Pain Relieving Liquid
Spl product data elements
Usually a list of ingredients in a drug product.Hush Anesthetic Lidocaine LIDOCAINE LIDOCAINE WATER ALCOHOL ALOE VERA LEAF PROPYLENE GLYCOL TROLAMINE GLYCERIN MENTHOL CHAMAEMELUM NOBILE FLOWER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF COMFREY ROOT CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETATE DISODIUM ANHYDROUS CAPRYLYL GLYCOL METHYLISOTHIAZOLINONE
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.4oz bottle
4oz die cut
2oz bottle
2oz die cut
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 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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Protect this product from excessive heat and direct sun.
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 305-231-7229 or visit www.hushanesthetic.com
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 or if symptoms persist more than 7 days or clear up and occur again with a few days
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 eyes
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