Minoxidil Topical Solution, 5% Solution
FDA Label NDC 51672-2151

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Minoxidil Topical Solution, 5% (NDC 51672-2151). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

Made in Israel

Active Ingredient

Minoxidil USP 5% w/v

Purpose

Hair regrowth treatment for men

Use

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

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Keep Out Of Reach Of Children

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

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 20° to 25° C (68° to 77° F)

Inactive Ingredients

alcohol (28.86% v/v), propylene glycol, purified water

Questions?

Call toll-free 1-866-923-4914

Principal Display Panel - 60 Ml Bottle Carton

NDC 51672-2151-4

One 60 mL (2 fl oz)

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