Label: CAPILLUS HAIR REGROWTH TREATMENT- minoxidil liquid
- NDC Code(s): 71176-781-02
- Packager: Capillus, Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 1, 2017
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- Drug Facts
- Active Ingredient
on the top of the scalp (vertex only, see picture on side of the carton).Close
For external use only. For use by men only.
Flammable: Keep away from fire of flame.
Do not use if
- you are a women
- your amount of hair loss is different than that shown on the side of this carton on your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline.
- you have no family history of hair loss;
- you 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 amount of cool tap water:
- soem 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 one mL with dropper 2 times a day directly onto the scalp in the hair loss area.
- Using more or more often will not improve results.
- Continued use is necessary of 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 leaflet;
- keep the carton. It contains important information;
- store at USP Controlled Room Temperature 20° to 25°C(68° to 77°F)
- Inacitve Ingredients
alcohol, propylene glycol, purified waterClose
Call 1(888)272-9599 or visit www.capillus.comClose
- Package Labeling:
- INGREDIENTS AND APPEARANCE
CAPILLUS HAIR REGROWTH TREATMENT
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71176-781 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 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:71176-781-02 1 in 1 BOX 01/24/2017 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 01/24/2017 Labeler - Capillus, Llc (079813345)