Label: WOMENS ROGAINE UNSCENTED- minoxidil aerosol, foam
- NDC Code(s): 69968-0030-1, 69968-0030-2, 69968-0030-3
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated March 2, 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 womenClose
to regrow hair on the top of the scalp (see pictures on side of this carton)Close
For external use only.
Do not use if
- your degree of hair loss is different than that shown on side of this carton because this product may not work for you
- you have no family history of hair loss
- your hair loss is sudden and/or patchy
- your hair loss is associated with childbirth
- 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 use more than directed
- 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 3 months with once daily use. For some women, you may need to use this product once a day for at least 6 months before you see results.
- the amount of hair regrowth is different for each person. This product will not work for all women.
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 6 months
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- see enclosed booklet for complete directions on how to use
- apply half a capful once daily directly to the scalp in the hair loss area
- massage into scalp with fingers, then wash hands well
- 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
- see hair loss pictures on side of this carton
- before use, read all information on carton and enclosed booklet
- keep the carton. It contains important information.
- store at controlled room temperature 20º to 25º C (68º to 77º 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 alcohol 40-B, stearyl alcoholClose
- call toll-free 800-ROGAINE or 215-273-8755 (collect)
- SPL UNCLASSIFIED SECTION
JOHNSON & JOHNSON
Skillman, NJ 08558
- PRINCIPAL DISPLAY PANEL - 60 g Can Carton
TO REGROW HAIR
Foam For Women
Four Month Supply
Two 60 g (2.11 oz) Cans
- INGREDIENTS AND APPEARANCE
WOMENS ROGAINE UNSCENTED
minoxidil aerosol, foam
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0030 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:69968-0030-1 1 in 1 CARTON 1 60 g in 1 CAN; Type 0: Not a Combination Product 2 NDC:69968-0030-2 2 in 1 CARTON 2 60 g in 1 CAN; Type 0: Not a Combination Product 3 NDC:69968-0030-3 3 in 1 CARTON 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 04/01/2011 Labeler - Johnson & Johnson Consumer Inc. (002347102)