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| Product NDC Code | 52454-001 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Fonow |
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| Type | Brand | ||||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OINTMENT | ||||||||
| RxCUI drug identifier | 2281302 | ||||||||
| Application Number | part333B | ||||||||
| Labeler Name | Zhejiang Fonow Medicine Co., Ltd. | ||||||||
| 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 (in each gram) Bacitracin 500 units Neomycin 3.5mg Polymyxin B 5000 units Lidocaine HCL 40 mg
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 2yrs. and older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily. may be cover with a sterile bandage Children under 2: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient White Petrolatum
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 Fist aid to help prevent infection and provide temporary pain relief in minor cuts scrapes burns
Purpose
Information about the drug product’s indications for use.Purpose First aid antibiotic First aid antibiotic First aid antibiotic Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Fonow Bacitracin, Neomycin, Polymyxin B, Lidocaine HCL PETROLATUM BACITRACIN BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B 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.PRINCIPAL DISPLAY PANEL Drug Facts Active ingredients (in each gram) Purpose Bacitracin 500 units .....................................................First aid antibiotic Neomycin 3.5mg ............................................................First aid antibiotic Polymyxin B 5000 units..................................................First aid antibiotic Lidocaine Hcl 40 mg........................ .... .... ... ........................ Anesthetic Uses Fist aid to help prevent infection and provide temporary pain relief in minor cuts scrapes burns Warnings For external use only. Do not use if allergic to any of the ingredients in or near the eyes over large areas of the body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition lasts or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Adults and children 2yrs. and older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily. may be cover with a sterile bandage Children under 2: ask a doctor Other information Store at temperature 50°-86℉(10°-30℃) Inactive ingredient White Petrolatum 52454-00-01-pouch-box-100 label 52545-001-02-tube-box label 52454-001-03-pouch-box-25 label
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.FONOW Triple Antibiotic Ointment With Pain Relief
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 allergic to any of the ingredients in or near the eyes over large areas of the body
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 immediately.
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 lasts or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction occurs
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.
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