PROFOLIX MINOXIDIL HAIR GROWTH SERUM liquid

PROFOLIX MINOXIDIL HAIR GROWTH SERUM by

Drug Labeling and Warnings

PROFOLIX MINOXIDIL HAIR GROWTH SERUM 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]

Active Ingredient

Minoxidil 5% w/v (without propellant)

Purpose

Hair Regrowth Treatment For Scalp and beard Only

Use

To Regrow hair, For Scalp and beard Only

Warnings

Keep away from kids.
for external use only
Flammable: Keep away from fire or flame
If swallowed, seek medical help, or contact poison control.
Store at controlled room temperature 20 to 25 ° C (68 to 77 ° F)
Do not expose to heat or store at temperature above 49 ° C (120 ° F)
Avoid fire, flame, or smoking during and immediately following application.

Do not use

your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
No family history of hair loss
Sudden or patchy hair loss
Unknown cause of hair loss
Under 18 years old (Avoid use on babies and children).
Red, inflamed, infected, irritated, or painful scalp.
Use of other scalp medications
May be harmful if used when pregnant or breast - feeding.

When Using

Apply only on the scalp or beard
Avoid contact with eyes (Rinse with cool water if contact occurs)

Stop Use

Experience chest pain, rapid heartbeat, faintness, or dizziness
Sudden, unexplained weight gain
Swelling of hands or feet
Scalp irritation or redness
Unwanted facial hair growth
No hair regrowth after 4 months

Ask Doctor

If have Allergy, plz check with doctor

Keep Oot Of Reach Of Children

Keep Oot Of Reach Of Children

Directions

Roll the roller gently across the treated scalp area, 5-10 times, in horizontal, vertical, and diagonal motions.
Apply 2-3 drops to the treated scalp area.
Massage in with fingers and wash hands thoroughly.
More serum or frequent use won't enhance results.
Consistent use is key for hair regrowth. Stopping may lead to hair loss.
Results may take at least 4 months with daily use (recommended: men: Once daily, Women: Twice daily)
Effectiveness varies from person to person.

IMPORTANT

The hair growth cycle is around 6 months. Consistent use is crucial for effectiveness, and visible results may appear after 3-4 months. Keep up the treatment post-initial improvements to sustain progress; discontinuation may lead to withdrawal.

Inactive ingredients

Water, Alcohol, Ginseng Extract, Ginger Extract, Carthamus Tinctorius L. Extract, Cortex Dictamni, Fructus Ligustri Lucidi Extract, Ligusticum Chuanxiong Hort Extract, Glycyrrhiza Uralensis Fisch Extract, Arctium Lappa L., Angelica Sinensis, Cacumen Platycladi Orientalis P.E., Polygonum Multiflorum Thunb, Capsaicin, Vitamin H (Biotin), Collagen.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROFOLIX MINOXIDIL HAIR GROWTH SERUM 
profolix minoxidil hair growth serum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81653-009
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
CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)
LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)
GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR)
CAPSAICIN (UNII: S07O44R1ZM)
BIOTIN (UNII: 6SO6U10H04)
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)
ALCOHOL (UNII: 3K9958V90M)
ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)
HOODIA GORDONII SAP (UNII: K7QNF2DJR8)
WATER (UNII: 059QF0KO0R)
GINGER (UNII: C5529G5JPQ)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
REYNOUTRIA MULTIFLORA STEM (UNII: 9V97G011CE)
ASIAN GINSENG (UNII: CUQ3A77YXI)
LIGUSTRUM LUCIDUM FRUIT (UNII: M9G2U96DUT)
COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81653-009-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2023
2	NDC: 81653-009-02	180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	11/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075357	11/12/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Jianyuan Biological Technology.Co.,Ltd		548120189	manufacture(81653-009)