Label: HAIR REGEN HAIR GROWTH TREATMENT- minoxidil liquid
- NDC Code(s): 84232-001-01
- Packager: YIWU YIZHOU TRADING CO.,LTD
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 8, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
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Do not use
- You are a woman.
- Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
- 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.
- You are under 18 years of age. Do not use on babies and children.
- Your scalp is red, inflamed, infected, rritated, or painful.
- You use other medicines on the scalp.
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When using this product.
●Do not apply on other parts of your body.
●Avoid contact with the eyes. In case accidental contact, rinse eyes with large amounts of cool tap water.
●Some people have experienced changes in hair color and/or texture.
●It takes time to regrow hai, results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
●The amount of hair regrowth is different for each person. This product will not work on all men,
- Stop use
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Other information
●See hair loss pictures on side of box
●Before use, read all information on box and enclosed instructions.
●Keep the box, it contains important information.
●Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical sol ution 5% for men.
●In Clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical sol lution 2%
●Store at 20° to 25*C (68° to 77*F). Keep tightly closed
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAIR REGEN HAIR GROWTH TREATMENT
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84232-001 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 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 5.6 mL in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 61.9 mL in 100 mL WATER (UNII: 059QF0KO0R) 27 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84232-001-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/09/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 04/09/2024 Labeler - YIWU YIZHOU TRADING CO.,LTD (840905001) Establishment Name Address ID/FEI Business Operations YIWU YIZHOU TRADING CO.,LTD 840905001 manufacture(84232-001)