Label: HAIR REGROW- 5% minoxidil topical solution solution
- NDC Code(s): 54111-205-60
- Packager: Bentley Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated January 11, 2018
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- Drug Facts
- Active ingredient
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
- 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, inflammed, infected, irritated, or painful
- you use other medicines on the scalp
- ASK DOCTOR
When using this product
- do not apply on other part of the body
- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- some individuals (people) have experienced changes in hair color and/or texture
- it takes time to regrow hair. Results may occur at 2 months with 2 times daily usage of this product. 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.
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- 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.
- hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solutions for men.
- In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth that 2% minoxidil topical solution.
- store at controlled room temperature 20° to 25° C (68° to 77° F)
- Inactive ingredients
Men's Extra Strength HAIR Regrow
Help regrow your hair with confidence
5% Minoxidil Topical Solution
Hair Regrowth Treatment
Extra Strength Formula
Reactivates hair follicles to stimulate regrowth
Minoxidil is clinically proven to help regrow hair
Compare to Men's Rogaine® Active Ingredient*
Not for use by women
30 day supply / 1-60 mL (2 fl oz) bottle
INGREDIENTS AND APPEARANCE
5% minoxidil topical solution solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-205 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:54111-205-60 1 in 1 CARTON 08/24/2004 1 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 08/24/2004 Labeler - Bentley Laboratories, LLC (068351753) Establishment Name Address ID/FEI Business Operations Ei LLC 105803274 analysis(54111-205) , manufacture(54111-205)