BOURN HAIR REGROWTH TREATMENT FOR MEN- minoxidil 5% solution 
Octri, Inc.

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bourn Minoxidil Topical Solution, USP 5% - Hair Regrowth Treatment for Men

Minoxidil 5% w/v

Hair regrowth treatment for men

USE

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Do not use if

■ You are a woman

■ Your amount of hair loss is dierent 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 and children.

■ Your scalp is red, inflamed, infected, irritated, or painful

■ You use other medicines on the scalp

Ask a doctor before use if you have heart disease

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 chances 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 and ask a doctor if

■ Chest pain, rapid heartbeat, faintness, or dizziness occurs

■ Sudden, unexplained weight gain occurs

■ Your hands or feet swell

■ Scalp irritation or redness occurs

■ Unwanted facial hair growth occurs

■ You do not see hair regrowth in 4 months

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DIRECTIONS

OTHER INFORMATION

• see hair loss pictures on 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 trials with

continuous treatment with 5% minoxidil topical solution for men

•in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5%

for men provided more hair regrowth than minoxidil topical solution 2%

• store at controlled room temperature 20º to 25ºC (68º to 77ºF)

alcohol, propylene glycol, purified water

Questions or comments? (909) 517-1177

label

BOURN HAIR REGROWTH TREATMENT FOR MEN 
minoxidil 5% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81553-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81553-001-016 in 1 BOX02/04/2021
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623902/04/2021
Labeler - Octri, Inc. (070111400)

Revised: 1/2023
Document Id: f1e96fe0-0675-26a8-e053-2a95a90ae60b
Set id: ba8ada1b-f362-4ec8-e053-2995a90a575a
Version: 3
Effective Time: 20230110
 
Octri, Inc.