FDA Label for Alcohol Cleansing

View Indications, Usage & Precautions

Alcohol Cleansing Product Label

The following document was submitted to the FDA by the labeler of this product Cmc Group Inc.. 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



Purified Water 99.1%

Ethyl alcohol 62%


Purpose



Eyewash

First aid antibiotic

First aid antiseptic

Pain relieving cream

Antiseptic


Use



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

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

Warnings



For external use only.

For external use only

For external use only.

Flammable, keep away from fire or flame
For external use only.


Do Not Use



if solution changes color or becomes cloudy

• 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 • 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.

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

• 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

  • irritation and redness develop
    • condition persists for more than 72 hours

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 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.


Directions



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

• 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
          • Wet hands thoroughly with product and allow to dry without wiping.

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)

Store at room temperature

Store at 15° to 25°C (59° to 77°F)


Inactive Ingredients



Benzalkonium chloride, sodium chloride

Mineral oil, petrolatum, purified water

glycerin monostearate, glycerol, purified water

Carbomer, propylene glycol, purified water, titanium dioxide


Active Ingredient:



Benzalkonium Chloride 0.13%

Isopropyl Alcohol, 70% v/v


Purpose:



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 preparation of the skin before injection.


Warnings:



For external use only.

For external use only.
Flammable - keep away from fire or flame.


Do Not Use:



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.

Wipe injection site vigorously and discard.


Inactive Ingredient:



Purified water.

Purified water.


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)


Ask A Doctor Before Use If You Have



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

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


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

Keep Out Of Reah 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.


Antiseptic Towelettes (49687-0016-0) Labeling:




Standard Ansi First Aid (49687-0020-0) Labeling:




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