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NDC 71176-0781-02 Capillus Hair Regrowth Treatment 50 mg/mL Details

Capillus Hair Regrowth Treatment 50 mg/mL

Capillus Hair Regrowth Treatment is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Capillus, Llc. The primary component is MINOXIDIL.

MedlinePlus Drug Summary

Minoxidil is used with other medications to treat high blood pressure. It is in a class of medications called vasodilators. It works by relaxing the blood vessels so that blood can flow more easily through the body. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Related Packages: 71176-0781-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Minoxidil

Minoxidil is used to stimulate hair growth and to slow balding. It is most effective for people under 40 years of age whose hair loss is recent. Minoxidil has no effect on receding hairlines. It does not cure baldness; most new hair is lost within a few months after the drug is stopped.

Related Packages: 71176-0781-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Minoxidil Topical

Product Information

NDC	71176-0781
Product ID	71176-781_4779865e-8ccc-2d96-e054-00144ff88e88
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Capillus Hair Regrowth Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	MINOXIDIL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	50
Active Ingredient Units	mg/mL
Substance Name	MINOXIDIL
Labeler Name	Capillus, Llc
Pharmaceutical Class	Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076239
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71176-0781-02 (71176078102)

Pricing Information	N/A
NDC Package Code	71176-781-02
Billing NDC	71176078102
Package	1 BOTTLE in 1 BOX (71176-781-02) / 60 mL in 1 BOTTLE
Marketing Start Date	2017-01-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 47793fa7-be6e-2266-e054-00144ff88e88 Details

Drug Facts

Active Ingredient

Minoxidil 5%

Purpose

Hair regrowth treatment for men

Use

on the top of the scalp (vertex only, see picture on side of the carton).

Warnings

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.

Ask a doctor before use if you

have heart disease.

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.

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 water

Questions?

Call 1(888)272-9599 or visit www.capillus.com

Package Labeling:

INGREDIENTS AND APPEARANCE

CAPILLUS HAIR REGROWTH TREATMENT

minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71176-781
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076239	01/24/2017

Labeler - Capillus, Llc (079813345)

Revised: 2/2017

Document Id: 4779865e-8ccc-2d96-e054-00144ff88e88

Set id: 47793fa7-be6e-2266-e054-00144ff88e88

Version: 1

Effective Time: 20170201