Label: 5% MINOXIDIL SPRAY.- 5% minoxidil spray liquid
- NDC Code(s): 83299-020-01
- Packager: Consilii LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
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Do not use
your amount of hair loss is different than that shown on side of this carton, or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
you have no family history of hair lossYou have no family history of hair loss,hair loss is sudden and/or patchy
you do not know the reason for your hair loss
you are under 18 years of age. Do not use it on babies and children
scalp is red,inflamed,infected,irritated,or painful
you use other medicines on th scalp
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When Using
Do not apply on other parts of the body
avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water
some people have experienced changes in hair color and/or texture
It takes time to regrow hair.Results may occur at 2 months with twice a day usage. For some men, You may need to use this product for at least 4 months before you see results
The amount of hair regrowth is different for each person. This product will not work for all men.
- Stop Use
- Ask Doctor
- Keep Oot Of Reach Of Children
- Directions
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Other information
see hair loss pictures on side of this carton
Before use, read all information on the carton
keep the carton.It contains important information.
hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical aerosol 5% for men
in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical aerosol 5% for men provided more hair regrowth than minoxidil topical aerosol 2%
Store at 20 to 25°C (68 to 77°F). Keep tightly closed.
- Inactive ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
5% MINOXIDIL SPRAY.
5% minoxidil spray liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83299-020 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 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CASTOR OIL (UNII: D5340Y2I9G) WATER (UNII: 059QF0KO0R) BIOTIN (UNII: 6SO6U10H04) ROSEMARY OIL (UNII: 8LGU7VM393) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) PANTHENOL (UNII: WV9CM0O67Z) NIACINAMIDE (UNII: 25X51I8RD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83299-020-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075357 11/01/2023 Labeler - Consilii LLC (118891890) Establishment Name Address ID/FEI Business Operations Consilii LLC 118891890 label(83299-020) , manufacture(83299-020)