Sinsin Pharmaceutical Co., Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Based on the above labeling evidence SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are intended for use as external analgesic drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Passage 2

Additionally, SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Passage 3

Specifically, according to your product’s labeling, your SINSINPAS AREX INSTANT PAIN RELIEF product is formulated with the active ingredients zinc oxide and mentha oil. However, zinc oxide and mentha oil are not permitted active ingredients under