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| Product NDC Code | 65197-811 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | ||||||
| RxCUI drug identifier | 2047877, 2047879 |
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| Application Number | part333A | ||||||
| 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 Purpose Benzalkonium Cl 0.13% w/w First aid antiseptic Lidocaine HCl 4% w/w Pain relieving spray
| Benzalkonium Cl 0.13% w/w | First aid antiseptic |
| Lidocaine HCl 4% w/w | Pain relieving spray |
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 and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first) children under 2 years, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients edetate disodium, fragrances, propylene glycol, purified 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 first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor: cuts scrapes minor burns sunburn minor skin irritations
Purpose
Information about the drug product’s indications for use.Active ingredients Purpose Benzalkonium Cl 0.13% w/w First aid antiseptic Lidocaine HCl 4% w/w Pain relieving spray
| Benzalkonium Cl 0.13% w/w | First aid antiseptic |
| Lidocaine HCl 4% w/w | Pain relieving spray |
Spl product data elements
Usually a list of ingredients in a drug product.Bactine Max benzalkonium chloride and lidocaine hydrochloride BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS EDETATE DISODIUM NONOXYNOL-9 PROPYLENE GLYCOL 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.PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 5 FL OZ (148 mL) Front Bottle Label
DRUG FACTS LABEL Bottle Label (Back)
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 4 FL OZ (118 mL) Rear Label First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 4 FL OZ (118 mL) First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 4 FL OZ (118 mL)
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.Drug Facts
Money Back Guarantee Manufactured for: WellSpring, Sarasota, FL 34243 ©2018 *germs commonly associated with skin infections.
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 animal bites serious burns
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, 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 Mon-Fri (8-5 EST) or www.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 use in or near the eyes do not apply over large areas of the body or in large quantities do not apply over raw surfaces or blistered areas
Storage and handling
Information about safe storage and handling of the drug product.Other information avoid 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 Ask a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use in or near the eyes do not apply over large areas of the body or in large quantities 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, 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