Label: 5% MINOXIDIL FOAM spray, suspension
- NDC Code(s): 83299-016-01, 83299-016-02
- Packager: Consilii LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 9, 2023
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- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
- Stop Use
- Ask Doctor
- Keep Oot Of Reach Of Children
- Directions
- Other information
- Inactive ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
5% MINOXIDIL FOAM
5% minoxidil foam spray, suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83299-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83299-016-01 60 g in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2023 2 NDC:83299-016-02 60 g in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075357 10/08/2023 Labeler - Consilii LLC (118891890) Establishment Name Address ID/FEI Business Operations Consilii LLC 118891890 label(83299-016) , manufacture(83299-016)