"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
No long-term studies in animals or humans have been conducted
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with Auralgan (antipyrine, benzocaine and glycerin dehydrated) . It is also not known whether Auralgan (antipyrine, benzocaine and glycerin dehydrated) can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Auralgan (antipyrine, benzocaine and glycerin dehydrated) should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Auralgan (antipyrine, benzocaine and glycerin dehydrated) is administered to a nursing woman.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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