U by Kotex Click Unscented Menstrual Tampons

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K113036 ↗

FDA Product Code

HEB

FDA applicant

Kimberly-Clark Corporation

Device Class

Class II

Regulation

21 CFR Part 884.5470

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Kimberly-Clark Child's Facemask

  Class II

  FDA 510(k) K113340 Active Cleared 4 May 2012

• Kotex Profile Shaped Maxi Pad

  Class I

  FDA 510(k) K871210 Active Cleared 10 Apr 1987

• Kimberly-Clark Self-Seal Pouch for Low Temperature Sterilization

  Class II

  FDA 510(k) K973827 Active Cleared 11 Feb 1998

• Kotex Security Tube Tampons

  Class II

  FDA 510(k) K885194 Active Cleared 1 Mar 1989

• Spunguard Face Mask Open recall

  Class II

  FDA 510(k) K823078 Active Cleared 7 Jan 1983

• Kotex Super Maxi Pads

  Class II

  FDA 510(k) K890013 Active Cleared 25 Apr 1989

See all devices from Kimberly-Clark Corporation →

• What is the U by Kotex Click Unscented Tampon designed for?

  The U by Kotex Click Unscented Tampon is designed for internal menstrual absorption during menstruation. It features a rayon-fiber pledget with a radially wound core, enclosed in a non-woven overwrap, and includes a withdrawal string for easy removal. The device is intended for single-use and home use only, providing comfort and convenience during periods.

• How are these tampons supplied, and what does the applicator look like?

  These tampons are supplied in a telescoping three-piece plastic applicator, which simplifies insertion. The applicator is designed to help users place the tampon comfortably inside the body. The device is non-sterile and intended exclusively for home use.

• Are the U by Kotex Click Unscented Tampons sterile, and can they be reused?

  No, these tampons are not sterile and are explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it may compromise hygiene and effectiveness. Each tampon is packaged individually for one-time use.

• What pack sizes are available for the U by Kotex Click Unscented Tampons?

  The product is distributed in various pack sizes, as indicated by the registration numbers listed in the FDA database (e.g., 3016010004, 3038182652, etc.). These packs vary in quantity, allowing users to choose based on their needs. Availability may depend on regional distribution.

• Are there any special storage instructions for these tampons?

  While the device data does not specify detailed storage instructions, standard best practices for menstrual products recommend keeping tampons in a cool, dry place away from direct sunlight. Avoid storing them in extremely hot or humid environments, as this could affect their integrity. Always check the packaging for any manufacturer-specific guidance.