Shalina Laboratories Limited · 66-41 · INDIA
For Shalina Laboratories Limited · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product is Diproson Lotion | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Super Apeti (Cyproheptadine 4 mg Tablets) | Super Apeti (Cyproheptadine 4 mg Tablets) | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Diproson Lotion | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline); product code is 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 56 D - - 21 Gentamicin Sulfate (Aminoglycosides) | 61 A - - 11 Iodochlorhydroxyquin (Anti-Amebic) | 61 W - - 31 Tolnaftate (Anti-Fungal) (Not Antibiotic) | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 X - - 99 Anti-Histaminic N.E.C. | 64 A - - 05 Cresol (Disinfectant) | 64 L - - 06 Betamethasone Dipropionate (Glucocorticoid) | 64 L - - 06 Betamethasone Dipropionate (Glucocorticoid) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 04/23/2015; address is 96 Maker Chamber V , Mumbai, Maharashtra INDIA, verified against its source on 2026-09-16.
- Firm
- Shalina Laboratories Limited verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- INDIA verified
- Address
- 96 Maker Chamber V , Mumbai, Maharashtra INDIA verified
- Date published
- 04/23/2015 verified
- Product code
- 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 56 D - - 21 Gentamicin Sulfate (Aminoglycosides) | 61 A - - 11 Iodochlorhydroxyquin (Anti-Amebic) | 61 W - - 31 Tolnaftate (Anti-Fungal) (Not Antibiotic) | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 X - - 99 Anti-Histaminic N.E.C. | 64 A - - 05 Cresol (Disinfectant) | 64 L - - 06 Betamethasone Dipropionate (Glucocorticoid) | 64 L - - 06 Betamethasone Dipropionate (Glucocorticoid) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Diproson Lotion | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Super Apeti (Cyproheptadine 4 mg Tablets) | Super Apeti (Cyproheptadine 4 mg Tablets) | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Diproson Lotion | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) | Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) each item verified
- FDA notes
- A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” | The product appears to be a drug, as per Section 201(g)(1) of the FD&C Act, 21 § 321(g)(1) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Labeling statements documenting the intended use of the product include, but may not be limited to, the following: “Super Apeti is an antihistaminic and antiserotonergic agent.” and “Super Apeti is indicated for the treatment of loss of appetite and allergy & pruritus.” | The product appears to be a drug, as per Section 201(g)(1) of the FD&C Act, 21 § 321(g)(1) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Labeling statements documenting the intended use of the product include, but may not be limited to, the following: “Super Apeti is an antihistaminic and antiserotonergic agent.” and “Super Apeti is indicated for the treatment of loss of appetite and allergy & pruritus.” | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” | 4/23/2015 | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” | A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” each item verified
What the source says
Shalina Laboratories Limited Date Published : 04/23/2015 96 Maker Chamber V , Mumbai, Maharashtra INDIA 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 04/23/2015 Desc: Diproson Lotion 56 D - - 21 Gentamicin Sulfate (Aminoglycosides) Date Published: 10/01/2021 Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” 61 A - - 11 Iodochlorhydroxyquin (Anti-Amebic) Date Published: 10/01/2021 Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” 61 W - - 31 Tolnaftate (Anti-Fungal) (Not Antibiotic) Date Published: 10/01/2021 Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) Date Published: 09/15/2021 Desc: Super Apeti (Cyproheptadine 4 mg Tablets) Notes: The product appears to be a drug, as per Section 201(g)(1) of the FD&C Act, 21 § 321(g)(1) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Labeling statements documenting the intended use of the product include, but may not be limited to, the following: “Super Apeti is an antihistaminic and antiserotonergic agent.” and “Super Apeti is indicated for the treatment of loss of appetite and allergy & pruritus.” 61 X - - 99 Anti-Histaminic N.E.C. Date Published: 09/15/2021 Desc: Super Apeti (Cyproheptadine 4 mg Tablets) Notes: The product appears to be a drug, as per Section 201(g)(1) of the FD&C Act, 21 § 321(g)(1) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Labeling statements documenting the intended use of the product include, but may not be limited to, the following: “Super Apeti is an antihistaminic and antiserotonergic agent.” and “Super Apeti is indicated for the treatment of loss of appetite and allergy & pruritus.” 64 A - - 05 Cresol (Disinfectant) Date Published: 10/01/2021 Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” 64 L - - 06 Betamethasone Dipropionate (Glucocorticoid) Date Published: 09/16/2019 Desc: Diproson Lotion Notes: 4/23/2015 64 L - - 06 Betamethasone Dipropionate (Glucocorticoid) Date Published: 10/01/2021 Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.” 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/01/2021 Desc: Epiderm Cream (Betamethasone Dipropionate/Gentamicin Sulphate/Tolnaftate/Iodochlorhydroxyquinoline) Notes: A labeling statement documenting the intended use of the product include, but may not be limited to the following: “…indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea infections of the skin (ringworm), Otitis externa, Seborrheic dermatitis, Contact dermatitis, Eczemas, Psoriasis, Athlete’s foot, Anal & vulval pruritis.” and “…is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.”
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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