Laboratorios Roldan S.A. · 66-41 · DOMINICAN REPUBLIC (THE)
For Laboratorios Roldan S.A., import alert is 66-41; country is DOMINICAN REPUBLIC (THE); import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Antimicrobial Soap; Jabon Germicida Roldan | Methodol Spray Analgesic Anti-inflammatory Anti-rheumatic | ?Mento-Dol Forte? Ointment | Antimicrobial Soap; Jabon Germicida Roldan | Antimicrobial Soap; Jabon Germicida Roldan | Antimicrobial Soap; Jabon Germicida Roldan | Antimicrobial Soap; Jabon Germicida Roldan | Antimicrobial Soap; Jabon Germicida Roldan; product code is 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 60 L - - 07 Camphorated Oil | 60 L - - 07 Camphorated Oil | 62 H - - 99 Anti-Microbial N.E.C. | 62 M - - 09 Liquid Phenol (Anti-Pruritic) | 64 A - - 20 Triclosan (Disinfectant) | 65 L - - 11 Titanium Dioxide (Protectant) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/06/2013; address is Carretera Sanchez Av Independencia, KM 5 , Santo Domingo, DOMINICAN REPUBLIC (THE), verified against its source on 2026-10-01.
- Firm
- Laboratorios Roldan S.A. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- DOMINICAN REPUBLIC (THE) verified
- Address
- Carretera Sanchez Av Independencia, KM 5 , Santo Domingo, DOMINICAN REPUBLIC (THE) verified
- Date published
- 06/06/2013 verified
- Product code
- 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 60 L - - 07 Camphorated Oil | 60 L - - 07 Camphorated Oil | 62 H - - 99 Anti-Microbial N.E.C. | 62 M - - 09 Liquid Phenol (Anti-Pruritic) | 64 A - - 20 Triclosan (Disinfectant) | 65 L - - 11 Titanium Dioxide (Protectant) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Antimicrobial Soap; Jabon Germicida Roldan | Methodol Spray Analgesic Anti-inflammatory Anti-rheumatic | ?Mento-Dol Forte? Ointment | Antimicrobial Soap; Jabon Germicida Roldan | Antimicrobial Soap; Jabon Germicida Roldan | Antimicrobial Soap; Jabon Germicida Roldan | Antimicrobial Soap; Jabon Germicida Roldan | Antimicrobial Soap; Jabon Germicida Roldan each item verified
- FDA notes
- A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. each item verified
What the source says
Laboratorios Roldan S.A. Date Published : 06/06/2013 Carretera Sanchez Av Independencia, KM 5 , Santo Domingo, DOMINICAN REPUBLIC (THE)
— accessdata.fda.gov, retrieved 2026-09-24
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 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 10/20/2021 Desc: Antimicrobial Soap; Jabon Germicida Roldan Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. 60 L - - 07 Camphorated Oil Date Published: 06/06/2013 Desc: Methodol Spray Analgesic Anti-inflammatory Anti-rheumatic 60 L - - 07 Camphorated Oil Date Published: 10/04/2013 Desc: ?Mento-Dol Forte? Ointment 62 H - - 99 Anti-Microbial N.E.C. Date Published: 10/20/2021 Desc: Antimicrobial Soap; Jabon Germicida Roldan Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. 62 M - - 09 Liquid Phenol (Anti-Pruritic) Date Published: 10/20/2021 Desc: Antimicrobial Soap; Jabon Germicida Roldan Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. 64 A - - 20 Triclosan (Disinfectant) Date Published: 10/20/2021 Desc: Antimicrobial Soap; Jabon Germicida Roldan Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. 65 L - - 11 Titanium Dioxide (Protectant) Date Published: 10/20/2021 Desc: Antimicrobial Soap; Jabon Germicida Roldan Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/20/2021 Desc: Antimicrobial Soap; Jabon Germicida Roldan Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “effective for the elimination of germs that affect the skin” and “has an antiseptic and antipruritic action”.
— all from accessdata.fda.gov, retrieved 2026-09-24
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html