U.S. Food and Drug Administration


Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300

3a. Directions for Use:


The following set of statements is an example of acceptable directions for use for latex condoms:


Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.


  1. Use a new condom for each act of sex.

  2. Tear open the package carefully. Do not use fingernails, teeth, or anything that can damage the condom.

  3. Before any sexual contact, place the condom on the head of the erect penis with the rolled side out.

    • Lesions, pre-ejaculate secretions, semen, vaginal secretions and blood can all transmit infectious organisms.

  4. Unroll or pull the condom all the way to the base of the erect penis. If the condom doesn’t unroll easily, it may be on backwards, damaged or too old. Throw it away and start over with a new condom.

  5. Immediately after ejaculation, hold the rim of the condom in place and withdraw the penis while it is still erect.

    • Avoid spilling semen.

  6. Dispose of a used condom by wrapping it in tissue and throwing it into the trash. Wash your hands with soap and water.



    The preceding directions can be found on this page or in the window below.


Introducing FDA-cleared O-Ring Condoms, designed for easy and quick application. Studies indicate that at least 30% of the time condoms are applied upside down. O-Ring Condoms feature a patented luminescent ring on the underneath side of the rolled condom. When the luminescent ring is facing down towards the body, the condom is ready to unroll.

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