Alcohol Cleansing
FDA Label NDC 50814-039

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gfa Production (xiamen) Co., Ltd. for the product Alcohol Cleansing (NDC 50814-039). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each gram), purpose, use, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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:

Kit (Kit)

Kit (Kit)

Kit2 (Kit2)

Kit2 (Kit2)

* Please review the disclaimer below.