Label: PROFOLIX MINOXIDIL HAIR GROWTH SERUM liquid
- NDC Code(s): 81653-009-01, 81653-009-02
- Packager: Guangzhou Jianyuan Biological Technology.Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 28, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
-
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
- Stop Use
- Ask Doctor
- 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
-
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 liquidProduct 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)