MENS MINOXIDIL HAIR REGROWTH- minoxidil 
Topiderm, Inc

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Mens Minoxidil Hair Regrowth System

Drug Facts

Active ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

Use

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

Warnings

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 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, inflamed, 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 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 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.

Directions

Other information

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

PRINCIPAL DISPLAY PANEL - Kit Carton

MINOXIDIL
HAIR REGROWTH SYSTEM

CLINICALLY PROVEN TO HELP REGROW HAIR

KIT CONTENTS: STRENGTHENING SHAMPOO, REJUVENATING CONDITIONER,
MINOXIDIL TOPICAL SOLUTION USP (2 MONTH SUPPLY)

PRINCIPAL DISPLAY PANEL - Kit Carton

PRINCIPAL DISPLAY PANEL - 2-60 ml Bottle Dropcard

MEN'S
MINOXIDIL
HAIR REGROWTH SYSTEM

5% MINOXODIL TOPICAL SOLUTION, USP

Reactivates hair follicles to
stimulate regrowth

Clinically proven to help regrow hair

Topical Solution

Unscented

Minoxidil Topical Solution 5% is for men who have
a general thinning of hair on the top of the scalp
(vertex only, as shown). Not intended for frontal baldness
or a receding hairline. Minoxidil Topical Solution 5%
has been shown to regrow hair in men with the following
degrees of thinning hair of hair loss

If men have more hair loss or hair loss in a place
different than shown above, Minoxidil Topical
Solution 5% may not work.

Two month supply
Two 60 ml (2 fl oz) bottles

PRINCIPAL DISPLAY PANEL - 2-60 ml Bottle Dropcard

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Shampoo

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

Strengthening
Basil Root
Shampoo

HAIR GROWTH SYSTEM

Clean | Volumize | Strengthen

Net 6.7 fl. oz. (200 ml)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Shampoo

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Conditioner

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

Rejuvenating
Basil Root
Conditioner

HAIR GROWTH SYSTEM

Condition | Volumize | Rejuvenate

Net 6.7 fl. oz. (200 ml)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Conditioner
MENS MINOXIDIL HAIR REGROWTH 
minoxidil kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-165
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-165-011 in 1 CARTON06/16/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE 120 mL
Part 21 BOTTLE 200 mL
Part 31 BOTTLE 200 mL
Part 1 of 3
MENS MINOXIDIL   HAIR GROWTH SYSTEM
minoxidil solution
Product Information
Item Code (Source)NDC:51326-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-160-1660 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623903/23/2021
Part 2 of 3
STRENGTHENING BASIL ROOT 
shampoos (non-coloring) shampoo
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
INGRSODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRDIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
INGRTRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRSPHINGANINE (UNII: YT0ZSD64HM)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRESCULIN (UNII: 1Y1L18LQAF)  
INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
INGRPOLIDOCANOL (UNII: 0AWH8BFG9A)  
INGRC11-15 ALKETH-7 (UNII: 261HPE0IS3)  
INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
INGRPOLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)  
INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
INGRPEG-55 PROPYLENE GLYCOL OLEATE (UNII: 7RDE7PJS40)  
INGRMENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)  
INGRTRIDECETH-12 (UNII: YFY3KG5Y7O)  
INGRACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRBASIL (UNII: 2U0KZP0FDW)  
INGRLOQUAT (UNII: DM9CY56A36)  
INGRPEA (UNII: W4X7H8GYFM)  
INGRAMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)  
INGRDEXTRAN 110 (UNII: 05Q25F6XJ3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC03/23/2021
Part 3 of 3
REJUVENATING BASIL ROOT CONDITIONER 
shampoos (non-coloring) shampoo
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRSTEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRTRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRSPHINGANINE (UNII: YT0ZSD64HM)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRRESVERATROL (UNII: Q369O8926L)  
INGRSILIBININ (UNII: 4RKY41TBTF)  
INGRCAFFEINE (UNII: 3G6A5W338E)  
INGRESCULIN (UNII: 1Y1L18LQAF)  
INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRZINC PIDOLATE (UNII: C32PQ86DH4)  
INGRCOPPER PIDOLATE (UNII: 497G7G1SL1)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRBASIL (UNII: 2U0KZP0FDW)  
INGRLOQUAT (UNII: DM9CY56A36)  
INGRPEA (UNII: W4X7H8GYFM)  
INGRTEA LEAF OIL (UNII: VC855RRT77)  
INGRDEXTRAN 110 (UNII: 05Q25F6XJ3)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC03/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623906/16/2023
Labeler - Topiderm, Inc (049121643)
Registrant - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topix Pharmaceuticals, Inc.117745066PACK(51326-165)

Revised: 6/2023
Document Id: d2337eb6-9792-4775-864d-1fdc9a9d1181
Set id: 80f91ed8-4f29-4a16-b2e5-fd74a11b6a61
Version: 3
Effective Time: 20230620
 
Topiderm, Inc