Label: LOESCH HAIR REGROWTH FORMULA UNSCENTED TOPICAL SOLUTION EXTRA-STRENGTH FOR MEN- minoxidil solution
- NDC Code(s): 25280-006-42
- Packager: Loesch Laboratory Consultant, INC.
- This is a repackaged label.
- Source NDC Code(s): 63981-798
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 26, 2019
If you are a consumer or patient please visit this version.
- Drug Facts
- Active Ingredients
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. 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 or children.
Your scalp is red, inflamed, infected, irritated, or painful.
You use other medicines on the scalp.
- ASK DOCTOR
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. Results may occur at 2 months with twice daily 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 everyone.
- Stop use and ask a doctor if you have
- Pregnancy or breast feeding
- Keep out of reach of children
See hair loss picture on the side of this carton.
Before use, read all information on carton and printed insert.
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 Minoxidil Topical Solution 5%.
In clinical studies with mostly caucasian men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair growth than Minoxidil Topical Solution 2%.
- Inactive Ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
LOESCH HAIR REGROWTH FORMULA UNSCENTED TOPICAL SOLUTION EXTRA-STRENGTH FOR MEN
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25280-006(NDC:63981-798) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 3 g in 60 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25280-006-42 1 in 1 PACKAGE 07/30/2014 1 60 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075598 07/30/2014 Labeler - Loesch Laboratory Consultant, INC. (026619510) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 relabel(25280-006)