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| Product NDC Code | 65197-832 | ||||
|---|---|---|---|---|---|
| Drug Name | Bactine max |
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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 | LIQUID | ||||
| Application Number | part348 | ||||
| Labeler Name | WellSpring Pharmaceutical Corporation | ||||
| 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 (w/w) Lidocaine 4%
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: shake well clean the affected area and apply a small amount up to 3 times daily and let dry a second coating may be applied for extra protection children under 2 years of age: ask doctor prior to use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylates copolymer, alcohol denat, ammonium acrylates copolymer, benzalkonium chloride, disodium deceth-6 sulfosuccinate, disodium EDTA, laureth-30, propanediol, sodium dehydroacetate, 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 or discomfort in minor cuts, scrapes and burns.
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.Bactine Max Lidocaine LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) ALCOHOL BENZALKONIUM CHLORIDE EDETATE DISODIUM PROPANEDIOL LAURETH-30 SODIUM DEHYDROACETATE WATER
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. PRINCIPAL DISPLAY PANEL New Bactine Max Liquid Bandage with Lidocaine Max Pain Relief Kills 99% of Germs Invisible Protection Relieves Kills Protects NO STING SHAKE WELL Bactine Max Liquid Bandage with Lidocaine Bactine Max Liquid Bandage with Lidocaine - Box Back Panel New Bactine Max Liquid Bandage with Lidocaine SHAKE WELL Bactine Max Liquid Bandageʼs unique formula provides maximum strength pain relief with LIDOCAINE, kills 99.9% of germs*, and protects hard-to-cover minor cuts and scrapes. This flexible bandage dries clear quickly and is breathable to maximize healing.
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.Distributed by: *Germs commonly associated with skin infections. Distributed by: WellSpring Pharmaceutical Corporation Sarasota, FL 34243 © 2022 WellSpring Pharmaceutical Corporation MONEY BACK GUARANTEE Bactine Max is FSA/HSA eligible.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have deep or puncture wounds deep cuts animal bites serious burns
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 in or near the eyes over large areas of the body longer than 1 week unless directed by a doctor
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, call a poison control center or get medical help 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? 1-844-241-5454 or Bactine.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 symptoms persist for more than 7 days, or clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not apply over raw surfaces or blistered areas
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature
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 Do not use If you are allergic to any of the ingredients in or near the eyes over large areas of the body longer than 1 week unless directed by a doctor Ask a doctor before use if you have deep or puncture wounds deep cuts animal bites serious burns When using this product do not apply over raw surfaces or blistered areas Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days, or clear up and occur again within a few days Keep out of reach of children If swallowed, call a poison control center or get medical help 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