Label: 5% MINOXIDIL HAIR REGROWTH FOAM- minoxidil aerosol, foam
- NDC Code(s): 85038-003-01, 85038-003-02, 85038-003-03
- Packager: Lianjiang Shanlilai E-commerce Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 11, 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
you are a woman.
your amount of hair loss is different than that shown on side ofthis carton or your hair loss is on the front of the scalp.5% minoxidilfoam is not intended for frontal baldness or receding hairline.
You have no family history of hair loss.
Your hair loss is sudden andjor 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.
You use other medicines on the scalp.
Your scalp is red, inflamed, infected, irritated, or painful. -
WHEN USING
Do not apply on other parts of the body.
Avoid contact with the eyes. in case of accidental contact, rinseeyes with large amounts of cool tap water.
Some people have experienced changes in hair color and,;or textureit takes time to regrow hair, Results may occur at 3 months withtwice a day usage. For some men, you may need to use this productfor at least 6 months before you see results.
The amount of hair regrowth is different for each person.This product will not work for all men. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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 lossarea.
Massage into scalp with fingers, then wash hands well.
Using more or more often will not improve results.
Continued use is necessary 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 HAIR REGROWTH FOAM
minoxidil aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:85038-003 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 LACTIC ACID (UNII: 33X04XA5AT) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CETYL ALCOHOL (UNII: 936JST6JCN) ALCOHOL (UNII: 3K9958V90M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CASTOR OIL (UNII: D5340Y2I9G) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:85038-003-01 1 in 1 PACKAGE 12/11/2024 1 60 g in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:85038-003-02 2 in 1 PACKAGE 12/11/2024 2 60 g in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:85038-003-03 3 in 1 PACKAGE 12/11/2024 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) 12/11/2024 Labeler - Lianjiang Shanlilai E-commerce Co., Ltd. (638192827) Establishment Name Address ID/FEI Business Operations Lianjiang Shanlilai E-commerce Co., Ltd. 638192827 manufacture(85038-003)