Label: MINOXIDIL 5% (FOR MEN)- minoxidil aerosol, foam
- NDC Code(s): 51672-2128-4, 51672-2128-9
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 27, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only.
For use by men only.
Do not use if
- you are a woman
- 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. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline.
- you have no family history of hair loss
- your 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 on babies and children.
- your scalp is red, inflamed, infected, irritated, or painful
- you use other medicines on the scalp
When using this product
- do not apply on other parts of the body
- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts 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 and ask a doctor if
- chest pain, rapid heartbeat, faintness, or dizziness occurs
- sudden, unexplained weight gain occurs
- your hands or feet swell
- scalp irritation or redness occurs
- unwanted facial hair growth occurs
- you do not see hair regrowth in 4 months
- apply half a capful 2 times a day to the scalp in the hair loss area
- massage into scalp with fingers, then wash hands well
- see enclosed leaflet for complete directions on how to use
- using more or more often will not improve results
- continued use is necessary to increase and keep your hair regrowth or hair loss will begin again
- hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
- see hair loss pictures on side of this carton
- before use, read all information on carton and enclosed leaflet
- keep the carton. It contains important information.
- store at controlled room temperature 20° to 25°C (68° to 77°F)
- contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 g Can Carton
INGREDIENTS AND APPEARANCE
MINOXIDIL 5% (FOR MEN)
minoxidil aerosol, foam
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1) Minoxidil 50 mg in 1 g Inactive Ingredients Ingredient Name Strength butylated hydroxytoluene (UNII: 1P9D0Z171K) cetyl alcohol (UNII: 936JST6JCN) anhydrous citric acid (UNII: XF417D3PSL) alcohol (UNII: 3K9958V90M) isobutane (UNII: BXR49TP611) lactic acid, unspecified form (UNII: 33X04XA5AT) butane (UNII: 6LV4FOR43R) polysorbate 60 (UNII: CAL22UVI4M) propane (UNII: T75W9911L6) water (UNII: 059QF0KO0R) stearyl alcohol (UNII: 2KR89I4H1Y) Product Characteristics Color WHITE (white to off-white foam) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2128-4 1 in 1 PACKAGE 01/02/2019 1 60 g in 1 CAN; Type 0: Not a Combination Product 2 NDC:51672-2128-9 3 in 1 PACKAGE 01/02/2019 2 60 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209074 01/02/2019 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(51672-2128)