FDA Label for Fak Care4 Bus And School Yellow Orm D

View Indications, Usage & Precautions

Fak Care4 Bus And School Yellow Orm D 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 Ingredients (In Each Gram)



Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)


Purpose



First aid antibiotic

First aid antiseptic

Pain relieving cream

Antiseptic

Topical Anesthetic
Antiseptic


Use



  • First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings



For external use only.

For external use only.


Do Not Use



• Do not use • in the eyes • over large areas of the body • if you are allergic to any of the ingredients

• longer than 1 week unless directed by a doctor.

• 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.

• deep or puncture 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.

• 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 Reach Of Children.



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. 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.

Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water.


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.

  • 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

Other Information



Store at room temperature

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


Inactive Ingredients



Mineral Oil, petrolatum, purified water

glycerin monostearate, glycerol, purified water


Active Ingredients



Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5


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.

Other Information



Store at room temperature


Active Ingredient:



Isopropyl Alcohol, 70% v/v

Benzalkonium Chloride 0.13%

Benzocaine, 6% w/v

SD alcohol,  60% w/v


Use:



For preparation of the skin before injection.

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

For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.


Warnings:



For external use only.

Flammable: keep away from fire or flame.

For external use only.

For external use only.


Do Not Use:



with electrocautery, in the eyes

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

In eyes, on broken skin, deep puncture wounds. If unusual redness,swelling, irritation or other symptoms occur, consult a physician immediately.


Stop Use



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


Directions:



Wipe injection site vigorously and discard.

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


Inactive Ingredient:



Purified water.

Purified water.


Purpose:



First Aid Antiseptic


Inactive Ingredients:



Purified water.


Package Labeling:




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