Label: REGENIVADE HAIR GROWTH FOAM (regenivade hair growth- serum foam liquid
- NDC Code(s): 81653-008-01, 81653-008-02, 81653-008-03
- Packager: Guangzhou Jianyuan Biological Technology.Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
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Do not use
Do not use if :
*You are a pregnant 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.5% minoxidil topical foam is not intended for frontal baldness or
receding hairline.
.You suffer from metal allergies
.You have no family history of hair loss.
.You 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.
*You scalp is red, inflamed, infected, irritated, or painful.
·You use other medicines on the scalp. -
When Using
●Do not apply on other parts of the body
●Avoid contact with the eyes. In case of 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 hair. Results may occur at 2 months withtwice a day usage. For some people, 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. Thisproduct will not work for all people. - Stop Use
- Ask Doctor
- Keep Oot Of Reach Of Children
- Directions
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Other information
.Hair growth has been shown in a clinical study of men (mostly
white) aged 18-49 years who used it for 4 months.
·Store at controlled room temperature 20°to 25°C (68° to 77°F)
contents under pressure. Do not puncture or incinerate container.
Do not expose to heat or store at temperatures above 120°F (49℃). -
Inactive ingredients
Aqua,hyaluronic acid, Cocamidopropyl betaine,keratin amino acids,tocopherol (vitamin E), glycerol, xanthan gum, Glyoxyloyl , allantoin, aloe barbadensis leaf extract, propylene glycol, vitas vinifera seed extract, polygonum cuspidatum extract, ethylhexlglycerin, biotin, argania spinosa kernel oil,simmondsia chinesis (jojoba) seed oil, castor oil, saw palmetto, peppermint oil,rosemary oil, pumpkin seed oil, caffeine, stinging nettle, niancinimide, Green tea.
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REGENIVADE HAIR GROWTH FOAM
regenivade hair growth (serum) foam liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81653-008 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 VITIS VINIFERA POLLEN (UNII: 83OVS854BE) WATER (UNII: 059QF0KO0R) SAW PALMETTO (UNII: J7WWH9M8QS) ROSEMARY OIL (UNII: 8LGU7VM393) URTICA DIOICA (UNII: 710FLW4U46) POLYGONUM CUSPIDATUM LEAF (UNII: 2540B7G25G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BIOTIN (UNII: 6SO6U10H04) JOJOBA OIL (UNII: 724GKU717M) PEPPERMINT OIL (UNII: AV092KU4JH) N-ETHYLHEXEDRONE (UNII: TAX3KSX6GY) HYALURONIC ACID (UNII: S270N0TRQY) GLYOXYLOYL CARBOCYSTEINE (UNII: 3K6008UJ5J) ALLANTOIN (UNII: 344S277G0Z) PUMPKIN SEED OIL (UNII: 6E5QR5USSP) CAFFEINE (UNII: 3G6A5W338E) NIACIN (UNII: 2679MF687A) GREEN TEA LEAF (UNII: W2ZU1RY8B0) XANTHAN GUM (UNII: TTV12P4NEE) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ARGAN OIL (UNII: 4V59G5UW9X) CASTOR OIL (UNII: D5340Y2I9G) AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81653-008-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/12/2023 2 NDC:81653-008-02 180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 11/12/2023 3 NDC:81653-008-03 360 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 11/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075357 11/12/2023 Labeler - Guangzhou Jianyuan Biological Technology.Co.,Ltd (548120189) Establishment Name Address ID/FEI Business Operations Guangzhou Jianyuan Biological Technology.Co.,Ltd 548120189 manufacture(81653-008)