Label: 5% MINOXIDIL SERUM liquid
- NDC Code(s): 83299-018-01
- Packager: Consilii LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 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
- Do not use
-
When Using
Do not apply on other parts of the body
Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water
It takes time to regrow hair. You may need to use this product 2 times a day for a least 4 months before you see results, The amount of hair regrowth is different for each person
- Stop Use
- Ask Doctor
- Keep Oot Of Reach Of Children
-
Directions
Sterilize the roller with alcohol before use
Clean the skin area and dry it
Apply roller gently on your skin, roll diagnoally, horizontally & vertically 4-5 times on target areas
Apply 2-3 drops of serum directly to the scalp in the area to be treated
Massage into the scalp with your finger then wash hand thoroughly
Always perform the test on a small area of the skin to make sure there is no allergic reaction
Initial shedding may occur as the new hairs push out older strands.
- Other information
- Inactive ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
5% MINOXIDIL SERUM
5% minoxidil serum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83299-018 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 BIOTIN (UNII: 6SO6U10H04) .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83299-018-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075357 10/31/2023 Labeler - Consilii LLC (118891890) Establishment Name Address ID/FEI Business Operations Consilii LLC 118891890 label(83299-018) , manufacture(83299-018)