FDA Label for Antiseptic Formula Filled Swab

View Indications, Usage & Precautions

Antiseptic Formula Filled Swab Product Label

The following document was submitted to the FDA by the labeler of this product Swabplus 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 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


* Please review the disclaimer below.