Label: ELEVATE HAIR REGROWTH TREATMENT 5- minoxidil solution
- NDC Code(s): 84561-524-00
- Packager: VAPOR PRO SHOPPE, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active ingredient
- Use
-
Warnings
For external use only. For use by men only.
Flammable:Keep away from fire or flame.
Do not use if:
- 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. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline
- 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
- your scalp is red, inflamed, infected, irritated, or painful
- you use other medicines on the scalp.
When using this product
- 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 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 for all men.
-
DIRECTIONS
- prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist
- apply one mL with spray (6 sprays) 2 times a day directly onto the scalp in the hair loss area
- using more or more often will not improve results
- continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
-
OTHER INFORMATION
- see hair loss pictures on side of this carton
- before use, read all information on carton and enclosed leaflet
- keep the carton. It contains important information.
- hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
- in clinical studies of mostly white men aged 18-45 years with moderte degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
- store at controlled room temperature 20° to 25°C (68° to 77°F).
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ELEVATE HAIR REGROWTH TREATMENT 5
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84561-524 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84561-524-00 1 in 1 BOX 07/16/2024 1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 07/16/2024 Labeler - VAPOR PRO SHOPPE, LLC (084088698)
