Label: GROWELL WOMENS HAIR REGROWTH TREATMENT 2 MINOXIDIL- minoxidil liquid
- NDC Code(s): 84329-466-00
- Packager: APIRA SCIENCE, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 16, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Use
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Warnings:
For external use only.
Flammable:Keep away from fire or flame
Do not use if:
- your degree of hair loss is different that than shown on the side of this carton because this product may not work on 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 apply on the 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. 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 everyone.
- Directions
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Other information
- See hair loss pictures on side of this carton
- before use, reatd all information on carton and enclosed leaflet
- keep the carton. It contains important information.
- hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5 % minoxidil topical solution for men
- in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: (19% of women reporting moderate hair regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
- store at controlled room temperature 20° to 25°C (68° to 77°F).
- Inactive ingredients
- Questions or comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
GROWELL WOMENS HAIR REGROWTH TREATMENT 2 MINOXIDIL
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84329-466 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84329-466-00 1 in 1 BOX 03/04/2024 1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078176 03/04/2024 Labeler - APIRA SCIENCE, INC. (010514721)
