Minoxidil Topical Solution, 5% — v4

Minoxidil Topical Solution, 5%

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Version

v4

Effective date

July 3, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
390a1dfe-c01a-60c6-e063-6294a90a62e2
Set ID
acc5ad74-4558-4be9-aab4-94ad9ddad6b2
Application numbers
ANDA217998
Product NDCs
51672-2151
Package NDCs
51672-2151-4, 51672-2151-9
Original packager NDCs

Names & Manufacturers

Brand names
Minoxidil Topical Solution, 5%
Generic names
MINOXIDIL SOLUTION
Manufacturer names
Sun Pharmaceutical Industries, Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
MINOXIDIL
Routes
TOPICAL
Pharmacologic class (PE)
Arteriolar Vasodilation [PE]
Pharmacologic class (EPC)
Arteriolar Vasodilator [EPC]
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
N0000175379, N0000175564
RxCUI
311724
UNII
5965120SH1
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Minoxidil USP 5% w/v
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have heart disease
Do Not Use (1)

Sequence 1

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, infected, irritated, or painful you use other medicines on the scalp
Dosage And Administration (1)

Sequence 1

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 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 with mostly white men aged 18 to 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 25º C (68º to 77º F)
Inactive Ingredient (1)

Sequence 1

Inactive ingredients alcohol (28.86% v/v), propylene glycol, purified water
Indications And Usage (1)

Sequence 1

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
Keep Out Of Reach Of Children (1)

Sequence 1

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

Sequence 1

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton NDC 51672-2151-4 One 60 mL (2 fl oz) Carton
Pregnancy Or Breast Feeding (1)

Sequence 1

May be harmful if used when pregnant or breast-feeding.
Purpose (1)

Sequence 1

Purpose Hair regrowth treatment for men
Questions (1)

Sequence 1

Questions? Call toll-free 1-866-923-4914
Spl Product Data Elements (1)

Sequence 1

Minoxidil Topical Solution, 5% Minoxidil Solution WATER ALCOHOL PROPYLENE GLYCOL MINOXIDIL MINOXIDIL
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Made in Israel
Stop Use (1)

Sequence 1

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
Warnings (1)

Sequence 1

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, 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 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. (1-800-222-1222)
When Using (1)

Sequence 1

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.

OpenFDA raw payload

{'application_number': ['ANDA217998'],
 'brand_name': ['Minoxidil Topical Solution, 5%'],
 'generic_name': ['MINOXIDIL SOLUTION'],
 'is_original_packager': [True],
 'manufacturer_name': ['Sun Pharmaceutical Industries, Inc.'],
 'nui': ['N0000175379', 'N0000175564'],
 'package_ndc': ['51672-2151-4', '51672-2151-9'],
 'pharm_class_epc': ['Arteriolar Vasodilator [EPC]'],
 'pharm_class_pe': ['Arteriolar Vasodilation [PE]'],
 'product_ndc': ['51672-2151'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['311724'],
 'spl_id': ['390a1dfe-c01a-60c6-e063-6294a90a62e2'],
 'spl_set_id': ['acc5ad74-4558-4be9-aab4-94ad9ddad6b2'],
 'substance_name': ['MINOXIDIL'],
 'unii': ['5965120SH1']}