Antibiotic Application Ointment
FDA Label NDC 49687-0013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cmc Group, Inc. for the product Antibiotic Application (NDC 49687-0013). 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 ingredient, purpose, use, warnings, do not use, when using this product, 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.

Label Section Quick Index

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:

Towelettes (Towelettes)

Towelettes (Towelettes)

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

Standard (Standard)

Standard (Standard)

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