5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution

5% MINOXIDIL TOPICAL Solution by

Drug Labeling and Warnings

5% MINOXIDIL TOPICAL Solution by is a Otc medication manufactured, distributed, or labeled by Nanhong (Zhuhai) Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

5% MINOXIDIL TOPICAL SOLUTION

ACTIVE INGREDIENT

MINOXIDIL 5%

PURPOSE

Hair regrowth treatment for men

INDICATIONS & USAGE

to regrow hair on the top of the scalp (vertex onlysee pictures on side of carton)

WARNINGS

For external use only. For use by men only.

Flammable: Keep away from fire or flame

DO NOT USE

you are a woman
your amount of hair loss is different than that shown onthe side of this carton, or your hair loss is on the front ofthe scalp.5% minoxidil topical solution is not intended forfrontal baldness or receding hairline.

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 babiesand children.

your scalp is red, inflamed, infected, irritated, or painful

you use other medicines on the scalp

WHEN USING

do not apply on other parts of the body

avoid contact with the eyes. In case of accidental contactrinse 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 2months with twice a day usage. For some men, you mayneed to use this product for at least 4 months before yousee results.

the amount of hair regrowth is different for each person.This product will not work for all men.

STOP USE

chest pain, rapid hearbeat, faintness, or dizziness occurs

sudden, unexplained weight gain occurs

your hands or feet swell

scalp irritation or redness occurs

unwanted facial hair growth occursyou do not see hair regrowth in 4 months

KEEP OUT OF REACH OF CHILDREN

May be harmful if used when pregnant or breast-feeding.Keep out of reach of children. lf swallowedget medical help or contact a Poison Control Centerright away.

DOSAGE & ADMINISTRATION

apply one mL with dropper 2 times a day directly ontothe scalp in the hair loss area

using more or more often will not improve results

continued use is necessary to increase and keep yourhair regrowth,or hair loss will begin again

STORAGE AND HANDLING

see hair loss pictures on side of this carton

before use, read all information on carton

keep the carton. lt contains important information.

5% minoxidil topical solution for men provided more hairregrowth than 2% minoxidil topical solution

store at controlled room temperature 20° to 25°C(68° to 77°F)

INACTIVE INGREDIENT

ALCOHOL
GLYCERIN
PROPYLENE GLYCOL
PURIFIED WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL TOPICAL SOLUTION 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85174-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85174-001-02	2 in 1 PACKAGE	01/16/2025
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 85174-001-03	3 in 1 PACKAGE	01/16/2025
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 85174-001-04	4 in 1 PACKAGE	01/16/2025
3		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
OTC Monograph Drug	505G(a)(3)	01/16/2025

Labeler - Nanhong (Zhuhai) Biotechnology Co., Ltd. (569163067)

Establishment
Name	Address	ID/FEI	Business Operations
Nanhong (Zhuhai) Biotechnology Co., Ltd.		569163067	manufacture(85174-001)