Regenivade Hair Growth Foam by Guangzhou Jianyuan Biological Technology.Co.,Ltd

Regenivade Hair Growth Foam by

Drug Labeling and Warnings

Regenivade Hair Growth Foam 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]

REGENIVADE HAIR GROWTH FOAM- 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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Active Ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair

Warnings

For external use only.

Do not use if:

You are a pregnant woman

Your amount of hair loss is different than that shown on the sideof this carton or your hair loss is on the front of the scalp. 5%minoxidil topical foam is not intended for frontal baldness orreceding hairline.

You suffer from metal allergies

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.

You 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 withtwice a day usage. For some people, you may need to use thisproduct for at least 4 months before you see results.The amount of hair regrowth is different for each person. Thisproduct 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.

lf swallowed, get medical help orcontact Poison Control Center right away.

Directions

Men: Apply half a capful 2 times a day to the hair loss area.

Women: Apply half a capful 1 time a day to the hair loss area.

Massage to area with fingers, then wash hands well.

Using more and more often will not improve results.

Other information:

Hair growth has been shown in a clinical study of men (mostly
white) aged 18-49 years who used it for 4 months.
Store at controlled room temperature 20° to 25° C (68° to 77° Fcontents under pressure. Do not puncture or incinerate container.Do not expose to heat or store at temperatures above 120°F(49°C)

Inactive Ingredient

Aqua, hyaluronic acid, cocamidopropyl betaine, keratin aminoacids, tocopherol(vitamin E), glycerol, xanthan gum, glyoxyloylallantoin, aloe barbadensis leaf extract, propylene glycol, vitasvinifera seed extract, polygonum cuspidatum extract,ethylhexlglycerin, biotin, argania spinosa kernel oil, simmondsiachinesis (jojoba) seed oil, castor oil, saw palmetto, peppermint oil.rosemary oil, pumpkin seed oil, caffeine, stinging nettle,niancinimide, green tea

1004

REGENIVADE HAIR GROWTH FOAM 
minoxidil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81653-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
NIACINAMIDE (UNII: 25X51I8RD4)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALLANTOIN (UNII: 344S277G0Z)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
HYALURONIC ACID (UNII: S270N0TRQY)  
CAFFEINE (UNII: 3G6A5W338E)  
URTICA DIOICA (UNII: 710FLW4U46)  
TEA TREE OIL (UNII: VIF565UC2G)  
XANTHAN GUM (UNII: TTV12P4NEE)  
REYNOUTRIA JAPONICA LEAF (UNII: 2540B7G25G)  
SAW PALMETTO (UNII: J7WWH9M8QS)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
JOJOBA OIL (UNII: 724GKU717M)  
WATER (UNII: 059QF0KO0R)  
HAIR KERATIN AMINO ACIDS (UNII: G46579QK1M)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYOXYLOYL CARBOCYSTEINE (UNII: 3K6008UJ5J)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BIOTIN (UNII: 6SO6U10H04)  
ARGAN OIL (UNII: 4V59G5UW9X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81653-007-011 in 1 PACKAGE10/23/2023
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/23/202311/21/2023
Labeler - Guangzhou Jianyuan Biological Technology.Co.,Ltd (548120189)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Jianyuan Biological Technology.Co.,Ltd548120189manufacture(81653-007)

Revised: 11/2023
 
Guangzho

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