Hair regrowth treatment by Guangzhou Jianyuan Biological Technology.Co.,Ltd 81653-005

Hair regrowth treatment by

Drug Labeling and Warnings

Hair regrowth treatment by is a Otc medication manufactured, distributed, or labeled by Guangzhou Jianyuan Biological Technology.Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAIR REGROWTH TREATMENT- minoxidil liquid 
Guangzhou Jianyuan Biological Technology.Co.,Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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81653-005

Minoxidil 5% w/v

Use to regrow hair on the top of the scalp (vertex only)

Remixidil Foam is for some people who have a general thinning of hair on the top of the scalp (vertex only, as shownbelow). Not intended for frontal baldness or a receding hairline. Remixidil Foam has been shown to regrow hair in some people with the following degrees of thinning hair or hair loss.

usage

For external use only.
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

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

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 occursunwanted facial hair growth occurs
you do not see hair regrowth in 4 months

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 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 2 months with twice a day usage.For some men, youmay 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 and women

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center right away.

apply half a capful 2 times a day to the scalp in the hair loss area
massage into scalp with fingers then wash hands well
see enclosed booklet for complete directions on how to use
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

store at controlled room temperature 20° to 25C (68° to 77°F)
contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store attemperatures above 120°F(49°c)
lngredients

before use, read all information on carton and enclosed leafletkeep the package, It contains important information

lnactive ingredients

Water, Polygonum multiflorum Thunb, Angelica Sinensis, Vitamin H.(Biotin), Cacumen Platycladi Orientalis, Ginseng Extract, Carthamus tinctorius L. Extract, Cortex Dictamni , Fructus Ligustri Lucidi Extract , Alcohol, Ligusticum Chuanxiong Hort Extract, Glycyrrhiza uralensis Fisch Extract, Capsaicin

Hair regrowth treatment for Men

111

Hair regrowth treatment for Women

000

HAIR REGROWTH TREATMENT 
minoxidil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81653-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
CAPSAICIN (UNII: S07O44R1ZM)  
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
PLATYCLADUS ORIENTALIS WHOLE (UNII: 835370K47L)  
LIGUSTRUM LUCIDUM FRUIT (UNII: M9G2U96DUT)  
GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR)  
REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)  
BIOTIN (UNII: 6SO6U10H04)  
WATER (UNII: 059QF0KO0R)  
CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81653-005-013 in 1 BOX10/25/2022
160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC: 81653-005-023 in 1 BOX10/25/2022
260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/20/202211/21/2023
Labeler - Guangzhou Jianyuan Biological Technology.Co.,Ltd (548120189)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Jianyuan Biological Technology.Co.,Ltd548120189manufacture(81653-005)

Revised: 11/2023
 
Guangzho

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