Label: HAIR REGROWTH 5% MINOXIDIL- minoxidil 5% solution
- NDC Code(s): 84033-007-01
- Packager: Qingdao Kuajie Online Electronic Technology Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 13, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- HOW TO USE
- WARNINGS
- STOP USE AND ASK A DOCTOR IF
-
DO NOT USE IF
your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline.
you have no family history of hair loss.
your 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.
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.
May be harmful if used when pregnant or breast-feeding. -
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, 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 men. - STORAGE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE
- PACKGE
-
INGREDIENTS AND APPEARANCE
HAIR REGROWTH 5% MINOXIDIL
minoxidil 5% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84033-007 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 BIOTIN (UNII: 6SO6U10H04) 3 g in 100 mL ALCOHOL (UNII: 3K9958V90M) 3 mL in 100 mL WATER (UNII: 059QF0KO0R) 83 mL in 100 mL CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5) 1 g in 100 mL POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) 1 g in 100 mL ANGELICA ROOT OIL (UNII: B25G881UOX) 0.5 g in 100 mL ASIAN GINSENG (UNII: CUQ3A77YXI) 2 g in 100 mL GINGER (UNII: C5529G5JPQ) 1 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84033-007-01 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209074 05/15/2024 Labeler - Qingdao Kuajie Online Electronic Technology Co., Ltd (974662026) Establishment Name Address ID/FEI Business Operations Qingdao Kuajie Online Electronic Technology Co., Ltd 974662026 manufacture(84033-007) , label(84033-007)
