Bliss GVS Pharma Limited · 66-41 · INDIA

Product code, Product and FDA notes

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 09/14/2021 Desc: FUNBACT-A Triple Action Cream Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’. 56 D - - 41 Neomycin Sulfate (Aminoglycosides) Date Published: 09/14/2021 Desc: FUNBACT-A Triple Action Cream Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’. 56 G - - 99 Antifungal N.E.C. Date Published: 09/14/2021 Desc: FUNBACT-A Triple Action Cream Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’. 61 H - - 99 Anti-Bacterial, N.E.C. Date Published: 09/14/2021 Desc: FUNBACT-A Triple Action Cream Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’. 61 W - - 04 Clotrimazole (Anti-Fungal) (Not Antibiotic) Date Published: 09/14/2021 Desc: FUNBACT-A Triple Action Cream Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’. 64 L - - 06 Betamethasone Dipropionate (Glucocorticoid) Date Published: 09/14/2021 Desc: FUNBACT-A Triple Action Cream Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/14/2021 Desc: FUNBACT-A Triple Action Cream Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘Indications . . . FUNBACT-A® provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision…’.