Atoma Anti-Itch Cream Recalled for Risks to Children

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Anti-itch cream not to be used for children under two years of age.

Thursday, January 16, 2020 - Taro Pharmaceuticals Inc. has issued a recall of Atoma Diphenhydramine Hydrochloride 2% Anti-Itch Cream due to labeling that does not properly warn against use of the product for children under two years of age. Tubes of the cream read that "application should be supervised by an adult," for young children. Labels should read that consumers should "consult a doctor" before using on children under two.

The affected lot of the product, used to treat itching due to sunburn, insect bites, bee stings, poison oak or ivy, and minor skin irritation is being pulled from store shelves, but consumers are not being asked to return Atoma Diphenhydramine Hydrochloride 2% Anti-Itch Cream to retailers. Instead, they should be made aware that the topical cream should not be used for children under two years old unless directed by a physician.

Use of the product on children younger than two years old can result in increased risk of side effects, including irritability or agitation, restlessness, or difficulty sleeping. More serious side effects include difficulty breathing, muscle spasms, and seizures.

if you have used this product on a child younger than two years old and are concerned about a possible reaction or side effect, consult your healthcare provider immediately.

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