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WARNING LETTER

June 26, 2023

RE: WL - 2575

Dear Ho Dong Yang:

The United States Food and Drug Administration (FDA) has reviewed your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug products, Hot Pap Cataplasma (NDC 72988-0007), Amuldy Sports Gel (NDC 72988-0023), Zenol Cool (NDC 72988-0026), Antiphlamine (NDC 72988-0028), Mentholatum (NDC 72988-0031), New Hanbang Col Cap (NDC 72988- 0032), Nocold-S (NDC 72988-0033), and Albothyl (NDC 72988-0035). Our review determined that your firm has submitted contradictory information between the labeling and the electronic listing files. As such, your firm is in violation of the Federal Food, Drug, and in Cosmetic Act (FD&C Act) as explained below.

We refer you to FDA’s drug listing deficiency letter notification dated March 17, 2023, describing the observed listing deficiencies in the information you submitted. We also refer you to FDA’s data removal email notification sent on May 1, 2023, informing you of a data removal action. As stated in this email, the continued deficiencies resulted in your products’ data removal from FDA’s Online NDC Directory.

Section 510(j)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 207 outline the requirements for registration and listing of drug products. In the case of your products’, Hot Pap Cataplasma (NDC 72988-0007), Amuldy Sports Gel (NDC 72988-0023), Zenol Cool (NDC 72988-0026), Antiphlamine (NDC 72988-0028), Mentholatum (NDC 72988-0031), New Hanbang Col Cap (NDC 72988-0032), Nocold-S (NDC 72988-0033), and Albothyl (NDC 72988-0035), there are various discrepancies between the labeling and the electronic listing files. The following table outlines the specific errors found in each listing submission for products.

 

Product name as submitted in the listing file	Product NDC	Error(s) found	Legal citation(s)
Hot Pap Cataplasma	72988-0007	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.	Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.
		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.	Under 21 CFR 207.49(a)(2), each registrant must provide the package type and volume information corresponding to the package code segment of the NDC.
Amuldy Sports Gel	72988-0023	1. 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.	Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.
Zenol Cool	72988-0026	1. 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.	Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.
Antiphlamine	72988-0028	1. 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.	Under 21 CFR 207.49(a)(6), each registrant must provide the dosage form for each listed drug.
Mentholatum,	72988-0031	1. 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.	Under 21 CFR 207.49(a)(4), each registrant must provide the name and the quantity of each active pharmaceutical ingredient in the listed drug.
New Hanbang Col Cap	72988-0032	1.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.	Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.
Nocold-S	72988-0033	1. 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.	Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.
		2. 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.	Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.
Albothyl	72988-0035	1. 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.	Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical ingredient in the listed drug.

Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, which is a prohibited act under section 301(p), 21 U.S.C. 360(j) and 331(p). In addition, failure to properly list a drug with FDA also renders it misbranded under section 502(o) of the FD&C Act, and in violation of section 301(a) of the FD&C Act, 21 U.S.C. 352(o) and 331(a).

Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.

We note that this warning letter only addresses registration and listing issues associated with your products. It is not intended to be an all-inclusive statement of violations that may exist in connection with your products. Your firm should investigate and determine the causes of any violations and take prompt actions to correct the violations and bring the products into compliance.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. In absence of a corrective action, the deficient listing data will not be available for certification under 21 CFR 207.57(b)(2) requirements and will be ultimately inactivated by FDA. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to eDRLS@fda.hhs.gov. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at eDRLS@fda.hhs.gov. for further assistance. Include the case identification number, 2575 on all correspondence.

Sincerely,
/S/
Tina Smith

CC: FDA District Office
CC: onbixus@gmail.com
Attn: U.S. Agent