Antiseptic Formula Filled Swab
FDA Label NDC 65734-270

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Swabplus Inc. for the product Antiseptic Formula Filled Swab (NDC 65734-270). 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, purpose, uses, keep out of reach of children, directions, warnings, administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzalkonium Chloride 0.11%

Lidocaine Hydrochloride 1.0%

Purpose

Benzalkonium Chloride    for Antiseptic

Lidocaine Hydrochloride   for Pain relief

Uses

Uses First aid to help prevent infection, and temporarily relieve pain and itching associated with minor cuts, scrapes and burns.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other.
  • Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip.
  • Apply the product to the affected area.
  • Discard swab after use.

Warnings

  • For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation occurs.
  • Do not use. longer than one week unless directed  by a doctor.
  • Stop use and ask a doctor if you have deep or puncture wounds, or serious burns, redness, irritation, swelling or pain continues or increase, infection occurs.

Administration

  • For adult and children 2 and older:Clean affected area and apply 1 to 3 times daily. May be covered with a bandage.
  • Children under 2 years of age: Do not use, consult a doctor. 

Other Information

Store at room temperature.Avoid direct sunlight, excessive heat and moistgure.

Inactive Ingredients

Dizolidinyl Urea, Methylparaben, Propylparben, water.

Patent

Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 Made in USA

The COLOR RING is copyrighted by Swabplus Inc. ©2007 SWABPLUS INC.

Package And Label

Image of antiseptic carton label

Image Of Antiseptic Carton Label (Antiseptic300270)

Image Of Antiseptic Carton Label (Antiseptic300270)

* Please review the disclaimer below.