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Product NDC Code | 50814-031 | ||||
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Drug Name | Fak large office first aid kit |
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Type | Brand | ||||
Dosage Form | KIT | ||||
RxCUI drug identifier | 204602, 581660, 797544, 1012100, 1038558, 1053429 |
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Application Number | part349B | ||||
Labeler Name | GFA Production (Xiamen) Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Benzalkonium Chloride 0.13% Purpose: First Aid Antiseptic
Active Ingredient: Benzalkonium Chloride 0.13% Purpose: First Aid Antiseptic
Active ingredients Benzalkonium chloride 0.13% Lidocaine hydrochloride 0.5% Purpose First aid antiseptic Pain relieving cream
Active Ingredient: Isopropyl Alcohol, 70% v/v Purpose: Antiseptic
Active ingredients (in each gram) Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units) Purpose First aid antibiotic
Active ingredient Ethyl alcohol 62% Purpose Antiseptic
Active ingredient Purified Water 99.1% Purpose Eyewash
Active ingredient Purified Water 99.1% Purpose Eyewash
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: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
Directions Clean the affected area Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily Children under 2 years of age: consult a doctor May be covered with a sterile bandage
Directions: Wipe injection site vigorously and discard.
Directions • Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.
Directions Wet hands thoroughly with product and allow to dry without wi
Directions • Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
Directions • Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient: Purified water.
Inactive ingredient: Purified water.
Inactive ingredients glycerin monostearate, glycerol, purified water
Inactive ingredient: Purified water.
Inactive ingredients Mineral oil, petrolatum, purified water
Inactive ingredients Carbomer, propylene glycol, purified water, titanium dioxide
Inactive ingredients Benzalkonium chloride, sodium chloride
Inactive ingredients Benzalkonium chloride, sodium chloride
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.Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.
Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.
Uses First aid to help prevent infection in minor cuts, scrapes, and burns. For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes
Use: For preparation of the skin before injection.
Use First aid to help prevent infection in minor cuts, scrapes, and burns.
Uses For handwashing to decrease bacteria on the skin Recommended for repeated use.
Use For cleansing the eye to help relieve irritation or burning by removing loose foreign material
Use For cleansing the eye to help relieve irritation or burning by removing loose foreign material
Purpose
Information about the drug product’s indications for use.Purpose: First Aid Antiseptic
Purpose: First Aid Antiseptic
Purpose First aid antiseptic Pain relieving cream
Purpose: Antiseptic
Purpose First aid antibiotic
Purpose Antiseptic
Purpose Eyewash
Purpose Eyewash
Spl product data elements
Usually a list of ingredients in a drug product.FAK Large Office First Aid kit BENZALKONIUM CHLORIDE Antiseptic Towelettes BENZALKONIUM CHLORIDE WATER BENZALKONIUM CHLORIDE BENZALKONIUM Antiseptic Towelette BENZALKONIUM CHLORIDE WATER BENZALKONIUM CHLORIDE BENZALKONIUM Burn Treatment BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE GLYCERIN WATER BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE Alcohol Cleansing ISOPROPYL ALCOHOL WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL Antibiotic Application BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE MINERAL OIL PETROLATUM WATER BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B Hand Sanitizer ALCOHOL CARBOXYPOLYMETHYLENE PROPYLENE GLYCOL WATER TITANIUM DIOXIDE ALCOHOL ALCOHOL Eye Wash WATER BENZALKONIUM CHLORIDE SODIUM CHLORIDE WATER 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 Labeling: Kit Kit2
Antiseptic Towelettes Antiseptic Towelettes
Antiseptic Towelette Antiseptic Towelette
Burn Treatment Burn Treatment
Alcohol Cleansing Alcohol Cleansing
Antibiotic Application Antibiotic Application
Hand Sanitizer Hand Sanitizer
Eyewash Eyewash
Eyewash2 Eyewash2
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.Antiseptic Towelettes - 113408 10 count (50814-011-01 ) DRUG FACTS
Antiseptic Towelette (50814-002-01) DRUG FACTS
Burn Treatment – 113402 10 count (50814-014-01) Drug Facts
Other information Store at room temperature
Alcohol Cleansing Pads - 113409, 20 count (50814-012-01) DRUG FACTS
Other information: Store at room temperature 15°-30° C (59°-86° F)
Antibiotic Application - 113401 10 count (50814-013-01) Drug Facts
Other information Store at room temperature
Hand Sanitizer – 117534 6 count (50814-015-01) Drug Facts
Other information Store at 15° to 25°C (59° to 77°F)
Eyewash - 117445 30ml (50814-010-01) Drug Facts
Other information • not for use as contact lens solution • use before expiration date marked on the bottle • store at room temperature, 5° to 35°C (41° to 95°F)
Eyewash 30ml (70897-002-03) Drug Facts
Other information • not for use as contact lens solution • use before expiration date marked on the bottle • store at room temperature, 5° to 35°C (41° to 95°F)
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.
Ask a doctor before use if you have • deep or punture wounds • 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: In the eyes, or over large areas of the body.
Do not use: In the eyes, or over large areas of the body.
Do not use • in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor
Do not use: with electrocautery, in the eyes
Do not use • in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.
Do not use in the eyes.
Do not use if solution changes color or becomes cloudy
Do not use if solution changes color or becomes cloudy
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. If unusual redness, swelling or other symptoms occur, consult a physician immediately.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.
Keep out of reah of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 • the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days
Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.
Stop use and ask a doctor if • the condition persists or gets worse • a rash or other allergic reaction develops.
Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours
Stop use and ask a doctor if • you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists
Stop use and ask a doctor if • you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists
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 • to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes
When using this product • to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes
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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately. Do not use: In the eyes, or over large areas of the body.
Warnings: For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately. Do not use: In the eyes, or over large areas of the body.
Warnings For external use only. Do not use • in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns. Stop use and ask a doctor if • the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reah of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings: For external use only. Flammable - keep away from fire or flame. Do not use: with electrocautery, in the eyes Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only. Do not use • in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor. Ask a doctor before use if you have • deep or punture wounds • animal bites • serious burns. Stop use and ask a doctor if • the condition persists or gets worse • a rash or other allergic reaction develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings Flammable, keep away from fire or flame For external use only. Do not use in the eyes. Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours Keep out of reach children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only. Do not use if solution changes color or becomes cloudy When using this product • to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes Stop use and ask a doctor if • you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only. Do not use if solution changes color or becomes cloudy When using this product • to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes Stop use and ask a doctor if • you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists 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