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Mommy's Bliss Nipple Cream Recall
June 05, 2008
The FDA has warned consumers against using Mommy's Bliss Nipple Cream. Here's an excerpt from the FDA statement.
The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, the ingredients contained in the product may be harmful to nursing infants.
Potentially harmful ingredients in Mommy's Bliss Nipple Cream are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.
Mothers and caregivers should watch for a decrease in an infant's appetite. More serious signs would be difficulty in awakening the child, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color. Please seek immediate medical attention if your child is showing these signs and symptoms.
Here's an excerpt from the statement by MOM Enterprises, the makers of Mommy's Bliss.
On the evening of May 23, the FDA issued a warning that consumers stop using the Nipple Cream.
The FDA had initiated discussions with us regarding the Nipple Cream on May 1st, 2008. Apparently the FDA had conducted an assessment of the product in early October but only now contacted the company. The FDA took over 6 months to inform us of this assessment which suggests that the FDA did not consider the product to pose a serious health hazard.
The product has been on the market for over a year and there have been no consumer complaints. On the contrary, the feedback on the product has been very positive.
The FDA is concerned primarily about infant ingestion of Chlorphenesin and Phenoxyethanol, two ingredients in this product which are used extensively as preservatives in many other cosmetic products. There is the potential of exposure of these two preservatives to nursing infants when using the Nipple Cream, but we have no evidence that this potential exposure at such a minute level is harmful.
However, even though we believe the product to be safe, we have stopped selling the product. We have notified all retail stores and distributors who have carried this product about the FDA warning and have asked them to remove the product from the shelf and return all unsold units to us. All individual consumers who purchased the Nipple Cream directly from us are being contacted and offered a full refund.
If you have the Mommy's Bliss Nipple Cream please dispose of it and call us, toll free, at 877-457-4955 for a refund.
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