Label: KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil spray
- NDC Code(s): 70550-578-01, 70550-578-02, 70550-578-03, 70550-578-04
- Packager: PROFECTUS BEAUTY, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 22, 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
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Warnings.
For external use only.
Flammable:Keep away from fire or flame
Do not use if
- your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
- your have no family history of hair loss
- your hair loss is sudden and/or patchy
- your hair loss is associated with childbirth
- you do not know the
- reason for your hair loss
- you are under 18 year 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 eye 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. You may need to use this product 2 times a day 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 everyone.
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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 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area
- using more often will not improve results
- continued use is necessary or hair loss will begin again
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Other Information
- see hair loss pictures on side of this carton
- before use, read all information on carton and enclosed booklet
- keep the carton. It contains important information.
- In clinical studies of mostly white women aged 18-45 years with mild to moderate diagnosis of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women imported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth, 40% had minimal regrowth). This compares with 7% of women reporting incidental hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth).
- Store at Controlled Room Temperature 20 to 25 C (68° to 77° F)
- Inactive Ingredients
- Questions or Comments?
- Package Labelling:70550-578-01
- Package Labelling:70550-578-02
- Package Labelling:70550-578-03
- Package Labelling:70550-578-04
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INGREDIENTS AND APPEARANCE
KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN
minoxidil sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70550-578 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 20 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:70550-578-01 1 in 1 BOX 07/17/2024 1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 2 NDC:70550-578-02 2 in 1 BOX 07/17/2024 2 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 3 NDC:70550-578-03 3 in 1 BOX 07/17/2024 3 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 4 NDC:70550-578-04 4 in 1 BOX 07/17/2024 4 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 ANDA078176 07/17/2024 Labeler - PROFECTUS BEAUTY, LLC (118310694)
