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Contaminated Nipple Cream

The Food and Drug Administration (FDA) is warning people not to use or buy Mommy's Bliss Nipple Cream because the product contains potentially harmful ingredients that may cause respiratory problems or vomiting and diarrhea in infants.

Marketed by MOM Enterprises Inc. in San Rafael, Calif., the product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. The product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, FDA is alerting the public because of the potential harm this product could have on nursing infants. To date, no injuries to infants have been reported to FDA.

Potentially Harmful Ingredients

The two potentially harmful ingredients in Mommy's Bliss Nipple Cream are chlorphenesin and phenoxyethanol, which may interact with one another to further increase the risk of slow or shallow breathing (respiratory depression) in nursing infants.

Chlorphenesin

• relaxes skeletal muscle
• can depress the central nervous system and cause respiratory depression in infants
• can cause a skin condition that can worsen the drying and cracking of nipple skin (dermatitis) in mothers

Phenoxyethanol

• is a preservative that is primarily used in cosmetics and medications
• can depress the central nervous system
• may cause vomiting and diarrhea, which can lead to dehydration in infants

Signs to Watch For

Get immediate medical attention if your child is showing the following signs and symptoms or if you are having difficulty awakening the child:

• decrease in appetite
• limpness of extremities or decrease in strength of grip and
• a change in skin color

What Consumers Should Do

• Discontinue use of Mommy's Bliss Nipple Cream.
• Consult a health care professional if you experience problems or believe your infant may have experienced problems due to the product.
• Speak with your health care professional or certified lactation consultant if your nipples are cracked or painful.
• Report adverse events related to the product to MedWatch at www.fda.gov/medwatch/report.htm or by calling 800-332-1088.

For More Information

FDA Press Release
www.fda.gov/bbs/topics/NEWS/2008/NEW01839.html

FDA MedWatch Web site
www.fda.gov/medwatch/

Date Posted: May 30, 2008

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