Label: 5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution
- NDC Code(s): 82429-200-60
- Packager: Gabar Health Sciences Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated November 22, 2022
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- ACTIVE INGREDIENT
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 baldmess 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
- ASK DOCTOR
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
- 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 directons 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
OTHER SAFETY 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 picture 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 20º to 25ºC (68º to 77ºF)
- contents under pressure. Do not puncture or incinerate container.
- do not expose to heat or store at temperature above 120ºF (49ºC).
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
5% MINOXIDIL TOPICAL SOLUTION
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82429-200 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ALCOHOL (UNII: 936JST6JCN) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DEHYDRATED ALCOHOL (UNII: 3K9958V90M) ISOBUTANE (UNII: BXR49TP611) LACTIC ACID (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:82429-200-60 60 mL in 1 PACKAGE; Type 0: Not a Combination Product 10/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/10/2022 Labeler - Gabar Health Sciences Corp. (118401847) Registrant - Gabar Health Sciences Corp. (118401847) Establishment Name Address ID/FEI Business Operations Gabar Health Sciences Corp. 118401847 manufacture(82429-200)