Label: SUAVECITO 5% MINOXIDIL SOLUTION- minoxidil liquid
- NDC Code(s): 74866-414-01, 74866-414-03
- Packager: SUAVECITO, INC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 18, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Use
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Warnings
For external use only. For use by men only
Flammable:Keep away from fire or flame
Do not use if
- you are a women
- your amount of hair loss is different than that shown on the side of this carton
- 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, 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
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Other information
- Store at Controlled Room Temperature 20º to 25ºC (68º to 77ºF)
- 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 18-49 years with moderate degrees of hair loss, 5% Minoxidil Topical Solution for men provided more hair regrowth than 2% Minoxidil Topical Solution
- Inactive Ingredients
- Questions or comments?
- Package Labeling:1 COUNT
- Package Labeling:3 COUNT
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INGREDIENTS AND APPEARANCE
SUAVECITO 5% MINOXIDIL SOLUTION
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74866-414 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:74866-414-01 1 in 1 BOX 07/31/2023 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:74866-414-03 3 in 1 BOX 07/31/2023 2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 07/31/2023 Labeler - SUAVECITO, INC. (078681797)