FDA MedWatch - TING 1% (tolnaftate) Athlete’s Foot Spray by Insight Pharmaceuticals

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TOPIC: TING 1% (tolnaftate) Athlete’s Foot Spray by Insight Pharmaceuticals: Recall - Due to the Presence of Benzene

AUDIENCE: Consumer, Health Professional, Pharmacy, Dermatology

ISSUE: Insight Pharmaceuticals is recalling two lots of TING 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid because a recent review by their manufacturer and their third-party lab found that samples from two lots of the product contained elevated levels of benzene. While benzene is not an ingredient in any Ting Antifungal Spray products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. Importantly, no other lots of TING 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid (either before or after these batch codes) and no other Ting Antifungal Spray Liquid products are in the scope of this recall and may continue to be used by consumers safely and as intended.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

The affected TING1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid lots were distributed nationwide in the United States through a limited number of retailers and online. 

To date, the Company has not received any serious adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The recalled product is used for:

• effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)

• effective relief of itchy, scaly skin between toes

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this antifungal product.

• Consumers that have product which is being recalled should stop using the product immediately and appropriately discard after taking the picture.

• The company will offer reimbursement for consumers who have purchased TING 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid marked with one of the following lot numbers.

•  Consumers can contact Insight Pharmaceuticals via e-mail at medicalaffairs@prestigebrands.com, through its website at https://www.prestigebrands.com/contact, or by phone at (800) 344-7239 on Monday – Friday 8:30-5:30 eastern time to receive a full refund by providing a picture of the bottom of the can of the TING 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid with the affected lot numbers, 0H50545 or 1G50645.

• Consumers with questions regarding this recall can contact Insight Pharmaceuticals via e-mail at medicalaffairs@prestigebrands.com, through its website at https://www.prestigebrands.com/contact, or by phone at (800) 344-7239 on Monday – Friday 8:30-5:30 eastern time. 

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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