Label: MINOXIDIL (FOR MEN)- minoxidil aerosol, foam
- NDC Code(s): 69113-128-01, 69113-128-03
- Packager: SCIENTIFIC HAIR RESEARCH, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 12, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only.
For use by men only.
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.
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 dosage. 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.
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Directions
- 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
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Other information
- 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
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 60 G Can Package
NDC 69113-128-01
BOSLEY MD®
*Compare to the
active ingredient of
Men's
Rogaine®#1 DERMATOLOGIST
RECOMMENDED
ACTIVE INGREDIENT†NOT FOR USE BY WOMEN
EASY-TO-USE FOAM
FOR MENMINOXIDIL TOPICAL
AEROSOL 5%
(FOR MEN)HAIR REGROWTH
TREATMENTUNSCENTED
REVITALIZES HAIR
FOLLICLESCLINICALLY
PROVEN
TO HELP
REGROW HAIRONE MONTH SUPPLY
ONE 60 G (2.11 OZ) CAN -
INGREDIENTS AND APPEARANCE
MINOXIDIL (FOR MEN)
minoxidil aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69113-128 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:69113-128-01 1 in 1 PACKAGE 12/23/2020 1 60 g in 1 CAN; Type 0: Not a Combination Product 2 NDC:69113-128-03 3 in 1 PACKAGE 12/23/2020 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 12/23/2020 Labeler - SCIENTIFIC HAIR RESEARCH, LLC (961897647)