Shalina Laboratories Limited · 66-41 · INDIA
For Shalina Laboratories Limited, import alert is 66-41; country is INDIA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.
- 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
— 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 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.”
— 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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