Label: HAIR SERUM- minoxidil 5% oil
- NDC Code(s): 83804-101-01
- Packager: Shenzhen Shandian Jingling Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 11, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAIR SERUM
minoxidil 5% oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83804-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ASIAN GINSENG (UNII: CUQ3A77YXI) ANGELICA SINENSIS ROOT OIL (UNII: T8CL3168L1) PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B) LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97) CORDIA DICHOTOMA WHOLE (UNII: 2G14524FFS) POLYGONATUM MULTIFLORUM ROOT (UNII: EYW899536C) SAFFLOWER (UNII: 4VBL71TY4Y) BIOTIN (UNII: 6SO6U10H04) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83804-101-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075357 11/10/2023 Labeler - Shenzhen Shandian Jingling Technology Co., Ltd. (418636058) Establishment Name Address ID/FEI Business Operations Shenzhen Shandian Jingling Technology Co., Ltd. 418636058 manufacture(83804-101)