Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Women
FDA Label NDC 69423-558

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Women (NDC 69423-558). 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.

Label Section Quick Index

Other

Drug Facts

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202.

Active Ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment for women

Use

to regrow hair on the top of the scalp

Warnings

For external use only.

Flammable: Keep away from fire or flame

Otc - Do Not Use

Do not use if

  • your degree of hair loss is different than that shown on side of this carton because this product may not work for you
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • your hair loss is associated with childbirth
  • 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

Otc - Ask Doctor

Ask a doctor before use if you have heart disease

Otc - When Using

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. You may need to use this product 2 times a day 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 allwomen.

Otc - Stop Use

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 6 months

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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.
  • store at 20-25° C (68-77° F)
  • contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Inactive Ingredients

alcohol,propylene glycol, purified water

Questions Or Comments?

1-800-723-9569

Principal Display Panel - Carton

Head & Shoulders

SCALP X

MINOXIDIL

TOPICAL SOLUTION USP, 2%

HAIR REGROWTH

TREATMENT

FOR WOMEN

CLINICALLY PROVEN TO HELP REGROW HAIR

Reactivates hair follicles to stimulate regrowth

Topical Solution

Three month supply

Unscented

3 - 60 mL (2 FL OZ) BOTTLES

TOTAL 180 mL (6 FL OZ)

Hs (Hs)

Hs (Hs)

* Please review the disclaimer below.