Obstetrical Antiseptic Towelette
FDA Label NDC 68345-881

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pss World Medical, Inc. for the product Obstetrical Antiseptic Towelette (NDC 68345-881). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient                                

Benzalkonium Chloride, 0.13% w/v

Otc - Purpose

Purpose

First Aid Antiseptic

Indications & Usage

Use Towelette to help prevent the risk of skin infection.

Warnings

Warnings

For external use only.

Do not insert into the vagina.

Otc - Do Not Use

Do not use  

  • in the eyes or apply over large areas of the body.

Otc - Stop Use

Consult a doctor in case of deep or puncture wounds, animal bites, or serious burns.

Stop use and consult a doctor if the condition persists or gets worse.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • Clean the affected area
  • Apply by gently patting 1 to 3 times daily or as directed by a doctor
  • May be covered with a sterile bandage when dry

Inactive Ingredient

Inactive ingredient: water, sodium bicarbonate, fragrance, o-phenylphenol

Otc - Questions

Questions or Comments about Select Medical Products? 800-777-4908

Description

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Made in China 

Package Label

Reorder #268

NDC 68345-881-50

268_Each

268_each (268 Each Final)

268_each (268 Each Final)

268_Box

268_box (268 Box Final)

268_box (268 Box Final)

268_Case

268_case (268 Case Final)

268_case (268 Case Final)

* Please review the disclaimer below.