Daytime and Nighttime Pack

Orajel™ Medicated Daytime & Nighttime Teething Twin Pack (discontinued)

The safety of our consumers and their children is our highest priority. Based on the May 23, 2018 communication from the U.S. Food and Drug Administration regarding over-the-counter (OTC) teething products containing benzocaine, we are discontinuing the distribution and sale of Orajel™ teething products containing benzocaine. Orajel™ teething products containing benzocaine and labeling have complied with applicable and evolving FDA requirements since we acquired the brand in 2008. The discontinuation is effective immediately and includes Orajel™ Medicated Teething Gel, Orajel™ Medicated Nighttime Teething Gel, Orajel™ Medicated Daytime & Nighttime Teething Twin Pack and Orajel™ Medicated Teething Swabs. We are not discontinuing other Orajel™ products, which represent the majority of our Orajel™ offering.

In addition, we also are revising the Drug Facts Label on all over-the-counter oral health care products that contain benzocaine with an intended use other than teething to emphasize that these products should not be used for teething pain or in children under 2 years of age. In addition, we are adding warning statements to more clearly identify the risks and symptoms presented by methemoglobinemia, a rare but serious condition associated with the use of benzocaine.

For more information, please visit www.fda.gov or call our Consumer Relations hotline at 1-800-952-5080.

1 Open

Cut along the scored line.

2 Rub

Using your finger or a cotton swab, apply a pea-size amount of gel and gently spread on your baby’s gums.

3 Dosage

Apply as necessary, up to 4 times daily or as directed by a Physician or Healthcare Provider.

For children under 2 years of age, consult a Physician or Healthcare Provider.

Daytime nighttime gel

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