TETMOSOL HELLO PRODUCTS · 66-41 · NIGERIA
For TETMOSOL HELLO PRODUCTS · 66-41 · NIGERIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is NIGERIA; product is Tetmosol Medicated Soap; product code is 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness); date published is 04/08/2020; address is Ikeja General Hospital St. , Lagos, Lagos NIGERIA, verified against its source on 2026-09-16.
- Firm
- TETMOSOL HELLO PRODUCTS verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- NIGERIA verified
- Address
- Ikeja General Hospital St. , Lagos, Lagos NIGERIA verified
- Date published
- 04/08/2020 verified
- Product code
- 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) verified
- Product
- Tetmosol Medicated Soap verified
- FDA notes
- Based on the product labeling, the article, "Tetmosol Medicated Soap," is a "drug" as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article (other than food) intended to cure, mitigate, treat, or prevent disease and/or to affect the structure or function of the body. Specifically, this product is intended for the treatment of one more diseases, including rashes caused by scabies.; Therefore, this product appears to be a new drug within the meaning of section 201(p) of the Act, 21 U.S.C. 321(p) because this product is not generally recognized as safe and effective under the conditions prescribed, recommended or suggested in the labeling. According to section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use. "Adequate directions for use" are directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined by section 503(b)(1)(A), of the FD&C Act, 21 U.S.C. 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner. "Tetmosol Medicated Soap" is intended for the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Thus, it is impossible to write adequate directions for a layperson to use this product safely for its intended purposes. Accordingly, the labeling for "Tetmosol Medicated Soap" fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the FD&C Act. verified
What the source says
TETMOSOL HELLO PRODUCTS Date Published : 04/08/2020 Ikeja General Hospital St. , Lagos, Lagos NIGERIA 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 04/08/2020 Desc: Tetmosol Medicated Soap Notes: Based on the product labeling, the article, "Tetmosol Medicated Soap," is a "drug" as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article (other than food) intended to cure, mitigate, treat, or prevent disease and/or to affect the structure or function of the body. Specifically, this product is intended for the treatment of one more diseases, including rashes caused by scabies.; Therefore, this product appears to be a new drug within the meaning of section 201(p) of the Act, 21 U.S.C. 321(p) because this product is not generally recognized as safe and effective under the conditions prescribed, recommended or suggested in the labeling. According to section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use. "Adequate directions for use" are directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined by section 503(b)(1)(A), of the FD&C Act, 21 U.S.C. 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner. "Tetmosol Medicated Soap" is intended for the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Thus, it is impossible to write adequate directions for a layperson to use this product safely for its intended purposes. Accordingly, the labeling for "Tetmosol Medicated Soap" fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the FD&C Act.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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