Zermat Internacional Sa De Cv · 66-41 · MEXICO
For Zermat Internacional Sa De Cv, import alert is 66-41; country is MEXICO; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima; product code is 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C; date published is 11/08/2018; address is Torre 3 , Calzada Melchor Ocampo 193; Colonia Veronica Anzures , Miguel Hidalgo, Ciudad de Mexico MEXICO, verified against its source on 2026-10-01.
- Firm
- Zermat Internacional Sa De Cv verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- MEXICO verified
- Address
- Torre 3 , Calzada Melchor Ocampo 193; Colonia Veronica Anzures , Miguel Hidalgo, Ciudad de Mexico MEXICO verified
- Date published
- 11/08/2018 verified
- Product code
- 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. each item verified
- Product
- Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima each item verified
- FDA notes
- Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). | Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). | Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). | Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). each item verified
What the source says
Zermat Internacional Sa De Cv Date Published : 11/08/2018 Torre 3 , Calzada Melchor Ocampo 193; Colonia Veronica Anzures , Miguel Hidalgo, Ciudad de Mexico MEXICO
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). 53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products) Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA).
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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