Label: 5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN- minoxidil aerosol, foam
- NDC Code(s): 83988-002-01, 83988-002-02, 83988-002-03
- Packager: Jinan Guyun Technology Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 30, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
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WHEN USING
Do not apply on other parts of the body.
Avoid contact with the eyes. In case of accidental contact, rinse eyes with largeamounts 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 davusage, for some people, you may need to use this product for at least 4months before you see results.
The amount of hair regrowth is different for each person. This product willnot work for all people. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Apply half a capful 2 times a day to the scalp in the hair loss area.
Massage into scalp with fingers, then wash hands well.
See enclosed leaflet for complete directions on how to use.
Using more or more often will not improve results.
Continued use is necessary to increase and keep your hair regrowth or hairloss will begin again.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN
minoxidil aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83988-002 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 g BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) BUTANE (UNII: 6LV4FOR43R) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) CASTOR OIL (UNII: D5340Y2I9G) ALCOHOL (UNII: 3K9958V90M) LACTIC ACID (UNII: 33X04XA5AT) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) ISOBUTANE (UNII: BXR49TP611) GLYCERIN (UNII: PDC6A3C0OX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83988-002-01 2 in 1 PACKAGE 10/31/2024 1 60 g in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:83988-002-02 4 in 1 PACKAGE 10/31/2024 2 60 g in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:83988-002-03 6 in 1 PACKAGE 10/31/2024 3 60 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 10/31/2024 Labeler - Jinan Guyun Technology Co., Ltd (544454964) Establishment Name Address ID/FEI Business Operations Jinan Guyun Technology Co., Ltd 544454964 manufacture(83988-002)
