Label Comp Study Proposed Pkg Insert-draft Guidance

LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE.DOC

Label Comprehension Study

LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE

OMB: 0910-0612

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XYZ Brand Latex Condoms

With spermicidal lubricant


Directions for Use:

  • Put the condom on after the penis is fully erect and before intimate contact. Lesions, pre-ejaculate secretions, semen, vaginal secretions, saliva, urine, and feces can all transmit disease organisms.

  • Place the condom on the head of the penis and unroll or pull it all the way to the base.

  • If the condom doesn’t unroll, the wrong side was placed against the penis. Do not flip the condom over. Throw it away and start over with a new condom.

  • Leave an empty space at the end of the condom to collect semen. Remove any air remaining in the tip of the condom by gently pressing the air out toward the base of the penis.

  • After ejaculation and while the penis is still erect, hold onto the rim of the condom so that the condom does not slip off as the penis is carefully withdrawn.


CAUTION: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.


Precautions:


  1. Use a new condom every time you have sexual intercourse or other acts between partners that involve contact with the penis.

  1. Do not reuse condoms.

  1. Store condoms in a cool, dry place.

  1. If the rubber material is sticky or brittle or obviously damaged, do not use the condom.

  1. If a lubricant is wanted, use water-based lubricants such as K-Y Jelly. DO NOT USE OIL-BASED LUBRICANTS, such as those made with petroleum jelly (e.g., Vaseline®), mineral oil, vegetable oil, or cold cream, as these may damage the condom.


Important Information:


When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of catching or spreading HIV, the virus that causes AIDS. Latex condoms can also reduce the risk of other sexually transmitted diseases (STDs), such as chlamydia and gonorrhea, that are spread to or from the penis by direct contact with the vagina and genital fluids.


Condoms provide less protection for certain STDs, including genital herpes and human papillomavirus (HPV) infection, that can also be spread by contact with infected skin outside the area covered by the condom. Condoms cannot protect against these STDs when they are spread in this way. Using latex condoms every time you have sex may still give you some benefits against these STDs. For example, using a condom may lower your risk of catching or spreading genital herpes. Using a condom also may lower your risk of developing HPV-related diseases, such as genital warts and cervical cancer.


For more information on STDs, consult your health care provider or information provided by government public health agencies.


Nonoxynol-9:


The lubricant on this condom contains the spermicide nonoxynol‑9 (N‑9), which kills sperm; however, the amount of additional pregnancy protection provided by the N-9 has not been measured.


The N‑9 lubricant on this condom does not protect against HIV/AIDS or other sexually transmitted diseases.


N-9 Warning:


  • N‑9 can irritate the vagina. This may increase the risk of getting HIV/AIDS from an infected partner.

  • If you or your partner has HIV/AIDS, or if you do not know if you or your partner is infected, you should choose a latex condom without N‑9.

  • You should not use condoms with N-9 for anal sex. N-9 can irritate the rectum and may increase the risk of getting HIV/AIDS from an infected partner.

Pregnancy Rates for Barrier Birth Control Methods

(For One Year of Use)

The following table provides estimates of the percent of women likely to become pregnant while using a particular contraceptive method for one year. These estimates are based on a variety of studies.


Typical Use” rates mean that the method either was not always used correctly or was not used with every act of sexual intercourse or was used correctly but failed anyway.


Method

Typical Use Rate of Pregnancy

No Method:

85%

Barrier Methods:

    Male Latex Condom Without Spermicide1

12%

    Diaphragm2

17%

    Cervical Cap (no previous births)2

17%

    Cervical Cap (previous births)2

30%

    Female Condom

21%

1 Typical pregnancy rates for a condom with spermicidal lubricant have not been determined.

2 Used with spermicide.

File Typeapplication/msword
File TitleDirections for use:
AuthorCDRH
Last Modified ByJonna Capezzuto
File Modified2007-07-02
File Created2007-07-02

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