NDC | 72764-002-01 |
Set ID | 815844f6-02f9-3952-e053-2a91aa0a1f52 |
Category | HUMAN OTC DRUG LABEL |
Packager | Brandable, Inc. |
Generic Name | |
Product Class | Arteriolar Vasodilator |
Product Number | |
Application Number | ANDA076239 |
- ACTIVE INGREDIENT
- PURPOSE
- Use
- WARNINGS
-
DO NOT USE
Do not use if:
- You are a woman
- Your amount of hair loss is different than shown on the side of this carton or 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 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 expereinced 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
- STOP USE
- Directions
-
Other Information
- See hair loss pictures on the 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 trialse with continuous treatment with 5% minoxidil topical solution for men
- In clincial studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provide more hair regrowth than 2% minoxidil topical solution
- Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)
- INACTIVE INGREDIENT
- QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GOOD GUY MENS HAIR REGROWTH TREATMENT
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72764-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72764-002-01 2 in 1 CARTON 02/07/2019 1 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 02/07/2019 Labeler - Brandable, Inc. (080414109) Registrant - Brandable, Inc. (080414109)