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| Product NDC Code | 65197-840 | ||||
|---|---|---|---|---|---|
| Drug Name | Bactine max lidocaine roll-on 2.5oz |
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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 | ||||
| RxCUI drug identifier | 1987647 | ||||
| Application Number | M017 | ||||
| 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 HCl 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: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period children 12 years or younger: ask a doctor children under 2 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf juice, carbomer, disodium EDTA, glycerin, phenylcarbinol, purified water, sodium hydroxide.
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 temporarily relieves minor pain
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Bactine Max Lidocaine Roll-on 2.5oz Lidocaine LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS WATER EDETATE DISODIUM GLYCERIN SODIUM HYDROXIDE ALOE VERA LEAF BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) translucent
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 NO MESS MAX PAIN RELIEF WITH LIDOCAINE Numbs Away Pain and Itch Fast Acting For Pain, Minor Burns, Bug Bites & Sunburn Max Strength Lidocaine No Mess Applicator Fast Acting With Aloe Vera Non-Greasy Quick Dry Formula HSA/FSA Eligible MONEY BACK GUARANTEE IMPORTANT: Keep this carton for future reference on full labeling. * Max Lidocaine HCL concentration per FDA External Analgesic OTC monograph NDC 65197-840-25 Bactine Max Roll-on Artwork CT84000A Bactine Max Roll-on Artwork 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: WellSpring Pharmaceutical Corporation Sarasota, FL 34243 © 2023 WellSpring Pharmaceutical Corporation
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 on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting 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 and pets If swallowed, get medical help or contact a Poison Control Center 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 use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes do not bandage or apply local heat (such as heating pads) to area of use
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 on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor When using this product use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes do not bandage or apply local heat (such as heating pads) to area of use 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 Flammable keep away from fire or flame If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center 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