Reference Source

Laboratorios Roldan S.A. · 66-41 · DOMINICAN REPUBLIC (THE)

For Laboratorios Roldan S.A. · 66-41 · DOMINICAN REPUBLIC (THE), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is DOMINICAN REPUBLIC (THE); product is Antimicrobial Soap; Jabon Germicida Roldan | ?Mento-Dol Forte? Ointment | Methodol Spray Analgesic Anti-inflammatory Anti-rheumatic | 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 2026-09-16.

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 | ?Mento-Dol Forte? Ointment | Methodol Spray Analgesic Anti-inflammatory Anti-rheumatic | 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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Laboratorios Roldan S.A. Date Published : 06/06/2013 Carretera Sanchez Av Independencia, KM 5 , Santo Domingo, DOMINICAN REPUBLIC (THE) 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: 10/04/2013 Desc: ?Mento-Dol Forte? Ointment 60 L - - 07 Camphorated Oil Date Published: 06/06/2013 Desc: Methodol Spray Analgesic Anti-inflammatory Anti-rheumatic 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”.

accessdata.fda.gov, retrieved 2026-09-15

Source

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