FDA-Drug2014-08-06Class II

Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.

Dermamedics, L.L.C.
Hazard

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Sold states
Nationwide
Affected count
unknown
Manufactured in
755 Research Pkwy Ste 150, Oklahoma City, OK, United States
Products
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1489-2014

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