Label: 5% MINOXIDIL HAIR REGROWTH SOLUTION WITH BIOTIN- minoxidil solution
- NDC Code(s): 83767-301-01, 83767-301-02, 83767-301-03
- Packager: Guangzhou Ruijiu Electronic Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 25, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DO NOT USE
You have no family history of hair loss.
Your hair loss is sudden and/or patchy.
Your hair loss is associated with childbirth.
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. - WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
5% MINOXIDIL HAIR REGROWTH SOLUTION WITH BIOTIN
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83767-301 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 0.2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) LACTIC ACID (UNII: 33X04XA5AT) CASTOR OIL (UNII: D5340Y2I9G) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83767-301-01 1 in 1 PACKAGE 07/26/2024 1 60 g in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:83767-301-02 2 in 1 PACKAGE 07/26/2024 2 60 g in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:83767-301-03 3 in 1 PACKAGE 07/26/2024 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 M032 07/26/2024 Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699) Establishment Name Address ID/FEI Business Operations Guangzhou Ruijiu Electronic Technology Co., Ltd. 631973699 manufacture(83767-301)