FDA Label for Fak Large Office First Aid Kit

View Indications, Usage & Precautions

Fak Large Office First Aid Kit Product Label

The following document was submitted to the FDA by the labeler of this product Gfa Production (xiamen) Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient:



Benzalkonium Chloride 0.13%

Benzalkonium Chloride 0.13%

Isopropyl Alcohol, 70% v/v


Purpose:



First Aid Antiseptic

First Aid Antiseptic

Antiseptic


Use:



For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

For preparation of the skin before injection.


Warnings:



For external use only.

For external use only.

For external use only.

Flammable - keep away from fire or flame.


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.

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.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.


Do Not Use:



In the eyes, or over large areas of the body.

In the eyes, or over large areas of the body.

with electrocautery, in the eyes


Directions:



Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Wipe injection site vigorously and discard.


Inactive Ingredient:



Purified water.

Purified water.

Purified water.


Active Ingredients



Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%


Purpose



First aid antiseptic

Pain relieving cream

First aid antibiotic

Antiseptic

Eyewash

Eyewash


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
    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use.

Warnings



For external use only.

For external use only.

Flammable, keep away from fire or flame

For external use only.

For external use only.

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

• 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.

in the eyes.

if solution changes color or becomes cloudy

if solution changes color or becomes cloudy


Ask A Doctor Before Use If You Have



• deep or puncture wounds • animal bites • serious burns.

• deep or punture 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

• the condition persists or gets worse • a rash or other allergic reaction develops.

  • irritation and redness develop
  • condition persists for more than 72 hours
  • • you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

    • you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists


Keep Out Of Reah Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


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
  • • 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.

    • Wet hands thoroughly with product and allow to dry without wi
    • • Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

      • Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle


Other Information



Store at room temperature

Store at room temperature

Store at 15° to 25°C (59° to 77°F)

• 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)

• 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)


Inactive Ingredients



glycerin monostearate, glycerol, purified water

Mineral oil, petrolatum, purified water

Carbomer, propylene glycol, purified water, titanium dioxide

Benzalkonium chloride, sodium chloride

Benzalkonium chloride, sodium chloride


Stop Use



if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.


Other Information:



Store at room temperature 15°-30° C (59°-86° F)


Active Ingredients (In Each Gram)



Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)


Use



  • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • For cleansing the eye to help relieve irritation or burning by removing loose foreign material

    For cleansing the eye to help relieve irritation or burning by removing loose foreign material


Active Ingredient



Ethyl alcohol 62%

Purified Water 99.1%

Purified Water 99.1%


Keep Out Of Reach Children.



If swallowed, get medical help or contact a Poison Control Center right away.


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

• 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


Package Labeling:




Eyewash




Eyewash2




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