Label: AZELOMAX FORTE- minoxidil 5% solution/ drops
- NDC Code(s): 73237-002-01
- Packager: TRILOGIC LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 10, 2023
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- Official Label (Printer Friendly)
- 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
- PREGNANCY OR BREAST FEEDING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
AZELOMAX FORTE
minoxidil 5% solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73237-002 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) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73237-002-01 1 in 1 BOX 07/10/2019 1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 07/10/2019 Labeler - TRILOGIC LTD (682372062)