Label: MENS ROGAINE MINOXIDIL - UNSCENTED FORMULA- minoxidil aerosol, foam
- NDC Code(s): 69968-0031-1, 69968-0031-3, 69968-0031-4
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated March 9, 2016
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
Minoxidil 5% w/w (without propellant)Close
Hair regrowth treatment for menClose
to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)Close
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- 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 booklet 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
- 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 package and enclosed booklet
- keep the package. 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
butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol40-B, stearyl alcoholClose
- call toll-free 800-ROGAINE or 215-273-8755 (collect)
- visit www.rogaine.com
- SPL UNCLASSIFIED SECTION
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558
- PRINCIPAL DISPLAY PANEL - Three 60 g Can Package
#1 DERMATOLOGIST RECOMMENDED BRAND
5% MINOXIDIL TOPICAL AEROSOL
HAIR REGROWTH TREATMENT
CLINICALLY PROVEN TO HELP REGROW HAIR
Not For Use By Women
Three Month Supply ∙ Three 60 g (2.11 oz) Cans
- INGREDIENTS AND APPEARANCE
MENS ROGAINE MINOXIDIL - UNSCENTED FORMULA
minoxidil aerosol, foam
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0031 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 Butane (UNII: 6LV4FOR43R) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Cetyl Alcohol (UNII: 936JST6JCN) Citric Acid Monohydrate (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Isobutane (UNII: BXR49TP611) Lactic Acid, Unspecified Form (UNII: 33X04XA5AT) Polysorbate 60 (UNII: CAL22UVI4M) Propane (UNII: T75W9911L6) Water (UNII: 059QF0KO0R) Stearyl Alcohol (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0031-1 1 in 1 PACKAGE 1 60 g in 1 CAN; Type 0: Not a Combination Product 2 NDC:69968-0031-3 3 in 1 PACKAGE 2 60 g in 1 CAN; Type 0: Not a Combination Product 3 NDC:69968-0031-4 4 in 1 PACKAGE 3 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 NDA NDA021812 10/01/2010 Labeler - Johnson & Johnson Consumer Inc. (002347102)