Refill 2 Kit
FDA Label NDC 49687-0016

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 Refill 2 (NDC 49687-0016). 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:, keep out of reach of children., do not use:, directions:, inactive ingredient:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

First Aid Antiseptic

Use:

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

Warnings:

For external use only.

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.

Do Not Use:

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

Directions:

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

Inactive Ingredient:

Purified water.

Active Ingredients (In Each Gram)

Bacitracin zinc (bacitracin 400 units)
Neomycin sulfate (neomycin 3.5mg)
Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic

Use

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

Warnings

For external use only

Do Not Use

• 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.

Ask A Doctor Before Use If You Have

• deep or punture 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.

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.

Inactive Ingredients

Mineral oil, petrolatum, purified water

Antiseptic Towelettes (49687-0016-0) Labeling:

Towelettes (Towelettes)

Towelettes (Towelettes)

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