The Food and Drug Administration on Friday warned women not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises Inc. of San Rafael, Calif.
The cream, promoted to nursing mothers to help soothe dry or cracked nipples, contains ingredients that may cause respiratory distress, vomiting and diarrhea in infants, the agency said.
The potentially harmful ingredients in the cream are chlorphenesin and phenoxyethanol.
"FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," said Janet Woodcock, director of the Center for Drug Evaluation and Research. "Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants."
The company has stopped selling the cream.
The FDA said consumers should stop using the cream and consult a doctor if they experience problems or believe that their infant may have experienced problems due to the product.
Mothers whose children may have suffered adverse effects because of this product should contact the FDA's MedWatch at 800-332-1088.