Lydia 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

The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling includes methyl salicylate and vanillyl nonylamide, the electronic listing file only includes the methyl salicylate.

Passage 2

There is incomplete package quantity information under the packaging section of the electronic listing file. Specifically, while the labeling indicates that the total quantity supplied is 5 sheets, with each sheet weighing 13.4 g, the packaging section of the electronic listing file, only includes package code of (1) which corresponds to one sheet or a total of 13.4 g. Another package code corresponding to the quantity of 5 sheets is not included.

Passage 3

The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling menthol, methyl salicylate, camphor and salicylic acid, the electronic listing file only includes menthol.

Passage 4

The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling includes menthol, and methyl salicylate, the electronic listing file only includes methyl salicylate.

Passage 5

There is a mismatched dosage form between the labeling and the electronic listing file. Specifically, While the labeling includes the dosage form as lotion, the electronic listing file includes the dosage form as ointment.

Passage 6

The strength of the active ingredients as expressed in the electronic listing file is misleading. Specifically, while the strength of the active ingredients, DL menthol and methyl salicylate in the labeling is expressed in milligrams/ gram, the strength of these active ingredients in the electronic listing file is expressed in milligrams/ milliliter.

Passage 7

The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the Drug Facts section of the labeling states, acetaminophen, caffeine anhydrous, chlorpheniramine maleate, and tipepidine hibenzate, the electronic listing file includes only acetaminophen and caffeine.

Passage 8

The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the active ingredients included in the product’s labeling appear to be acetaminophen and chlorpheniramine, the nonproprietary name field in the electronic listing file, includes the active ingredients as acetaminophen and caffeine.

Passage 9

There is mismatched strength of the active ingredient, chlorpheniramine, between the labeling and the electronic listing file. Specifically, while the strength in the labeling is 2.5 mg in 20 ml, the strength of chlorpheniramine in the electronic listing file is included as 200 mg in 20 ml.

Passage 10

There is mismatched or misleading strength of active ingredient, policresulen, between the labeling and the electronic listing file. Specifically, while the strength, included in the labeling is 720 mg/g, the strength for policresulen in the electronic listing file is 720 mg in 1 ml.