MENS MINOXIDIL HAIR REGROWTH- minoxidil kit

Mens Minoxidil Hair Regrowth by

Drug Labeling and Warnings

Mens Minoxidil Hair Regrowth by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc, Topiderm, Inc., Topix Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
• using more or more often will not improve results
• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other information

• see hair loss pictures on opposite side
• before use, read all information on carton and enclosed leaflet
• keep the insert. 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, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
• store at controlled room temperature 20º to 25ºC (68º to 77ºF).

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 - 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 - 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-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

INGREDIENTS AND APPEARANCE

MENS MINOXIDIL HAIR REGROWTH 
minoxidil kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-165

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-165-01	1 in 1 CARTON	06/16/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BOTTLE	120 mL
Part 2	1 BOTTLE	200 mL
Part 3	1 BOTTLE	200 mL

Part 1 of 3

MENS MINOXIDIL   HAIR GROWTH SYSTEM
minoxidil solution

Product Information
Item Code (Source)	NDC: 51326-160
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: 51326-160-16	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	03/23/2021

Part 2 of 3

STRENGTHENING BASIL ROOT 
shampoos (non-coloring), rinse-off [hair preparations (non-coloring)] shampoo

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
INGR	SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
INGR	SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
INGR	TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	SPHINGANINE (UNII: YT0ZSD64HM)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	ESCULIN (UNII: 1Y1L18LQAF)
INGR	GLYCOL DISTEARATE (UNII: 13W7MDN21W)
INGR	POLIDOCANOL (UNII: 0AWH8BFG9A)
INGR	C11-15 ALKETH-7 (UNII: 261HPE0IS3)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)
INGR	POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
INGR	PEG-55 PROPYLENE GLYCOL OLEATE (UNII: 7RDE7PJS40)
INGR	MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)
INGR	TRIDECETH-12 (UNII: YFY3KG5Y7O)
INGR	ACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BASIL (UNII: 2U0KZP0FDW)
INGR	LOQUAT (UNII: DM9CY56A36)
INGR	PEA (UNII: W4X7H8GYFM)
INGR	AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)
INGR	DEXTRAN 110 (UNII: 05Q25F6XJ3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		200 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
COSMETIC		03/23/2021

Part 3 of 3

REJUVENATING BASIL ROOT CONDITIONER 
hair conditioners, rinse-off [hair preparations (non-coloring)] shampoo

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
INGR	TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	SPHINGANINE (UNII: YT0ZSD64HM)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	RESVERATROL (UNII: Q369O8926L)
INGR	SILIBININ (UNII: 4RKY41TBTF)
INGR	CAFFEINE (UNII: 3G6A5W338E)
INGR	ESCULIN (UNII: 1Y1L18LQAF)
INGR	POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	ACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	ZINC PIDOLATE (UNII: C32PQ86DH4)
INGR	COPPER PIDOLATE (UNII: 497G7G1SL1)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BASIL (UNII: 2U0KZP0FDW)
INGR	LOQUAT (UNII: DM9CY56A36)
INGR	PEA (UNII: W4X7H8GYFM)
INGR	TEA LEAF OIL (UNII: VC855RRT77)
INGR	DEXTRAN 110 (UNII: 05Q25F6XJ3)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		200 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
COSMETIC		03/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076239	06/16/2023

Labeler - Topiderm, Inc (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topix Pharmaceuticals, Inc.		117745066	PACK(51326-165)