Label: 5% MINOXIDIL FOAM- minoxidil aerosol, foam
- NDC Code(s): 83767-002-01, 83767-002-02
- Packager: Guangzhou Ruijiu Electronic Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 12, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
DO NOT USE
your degree of hair loss is different than that shown on side of thiscarton because this product may not work for you.
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.
Your halr loss is associated with childbirth.
You are under 18 years of age. Do not use on babies and children.
You use other medicines on the scalp.
Your scalp is red, inflamed, infected, irritated, or painful. -
WHEN USING
Do not use more than directed.
Do not apply on other parts of the body.
Avoid contact with the eyes. In case of accidental contact, rinse eyeswith large amounts of cool tap water.
For some women, you may need to use this product once a day forat least 6 months before you see results.
The amount of hair regrowth is different for each person. Thisproduct will not work for all women. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
See enclosed leaflet for complete directions on how to use.
Apply half a capful twice daily directly to the scalp in the hair loss area.
Massage into scalp with fingers, then wash hands well.
Using more or more often will not improve results.
Continued use is necessany to increase and keep your hair regrowthor hair loss will begin again. - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
5% MINOXIDIL FOAM
minoxidil aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83767-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 0.5 g in 100 g MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 2 g in 100 g Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) LACTIC ACID (UNII: 33X04XA5AT) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) CETYL ALCOHOL (UNII: 936JST6JCN) POLYSORBATE 80 (UNII: 6OZP39ZG8H) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83767-002-01 2 in 1 PACKAGE 09/12/2024 1 60 g in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:83767-002-02 3 in 1 PACKAGE 09/12/2024 2 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) 09/12/2024 Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699) Establishment Name Address ID/FEI Business Operations Guangzhou Ruijiu Electronic Technology Co., Ltd. 631973699 manufacture(83767-002)