ELEVATE HAIR GROWTH SERUM by Guangzhou Jianyuan Biological Technology Co., Ltd. 81653-010

Drug Details [pdf]

ELEVATE HAIR GROWTH SERUM- 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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81653-010

Active ingredient

Minoxidil 5% w/v

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Purpose

Hair Growth Serum for people

Warnings

For external use only
Flammable: Keep away from fire or flame

Do not use if

■ our amount of hair loss is different than that shown the side of this carton or your hair loss is on the front of the scalp. Hair Growth Serum is not intended for frontal baldness or receding hairline

■ you have no family history of hair loss

■ your hair loss is sudden and/or patch

■ 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 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 people, 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 people

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.

Other information

keep the carton. t contains important information.
store at 20° to 25°C (68°to 77°F). Keep tightly closed.

Directions

■ Apply 1 ml twice a day directly onto the scalp in the hair loss area

■ massage into scalp with fingers, then wash hands well

■ 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

Ingredients

Reynoutria Multiflora Whole

Angelica Sinensis Whole

Biotin

Platycladus Orientalis Leaf

Asian Ginseng

Carthamus Tinctorius Whole

Dictamnus Dasycarpus Root Bark

Ligustrum Lucidum Fruit

Alcohol

Ligusticum Sinense Subsp. Chuanxiong Root

Glycyrrhiza Uralensis Whole

Capsaicin

MARINE COLLAGEN SOLUBLE

Ginger

Arctium Lappa Whole

Label

ELEVATE HAIR GROWTH SERUM
minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81653-010
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)
PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)
LIGUSTRUM LUCIDUM FRUIT (UNII: M9G2U96DUT)
GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR)
CAPSAICIN (UNII: S07O44R1ZM)
DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)
ALCOHOL (UNII: 3K9958V90M)
ASIAN GINSENG (UNII: CUQ3A77YXI)
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)
BIOTIN (UNII: 6SO6U10H04)
CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)
GINGER (UNII: C5529G5JPQ)
ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)
WATER (UNII: 059QF0KO0R)
REYNOUTRIA MULTIFLORA WHOLE (UNII: 85S46HFR8A)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81653-010-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/04/2023	12/28/2023

Labeler - Guangzhou Jianyuan Biological Technology Co., Ltd. (548120189)

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Jianyuan Biological Technology Co., Ltd.		548120189	manufacture(81653-010)

Revised: 12/2023

Document Id: 0d8c01d2-e68f-4d50-e063-6394a90aadc4

Set id: 0bab4001-f409-695f-e063-6294a90a1717

Version: 3

Effective Time: 20231228

Guangzhou