Loesch® Hair Regrowth Formula - Unscented Topical Solution - Regular-Strength Minoxidil 2% for Men and Women

Loesch® Hair Regrowth Formula - Unscented Topical Solution - Regular-Strength Minoxidil 2% for Men and Women

Drug Labeling and Warnings

Drug Details

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LOESCH HAIR REGROWTH FORMULA UNSCENTED TOPICAL SOLUTION REGULAR-STRENGTH FOR MEN AND WOMEN- minoxidil solution 
Loesch Laboratory Consultants, Inc.

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Loesch® Hair Regrowth Formula - Unscented Topical Solution - Regular-Strength Minoxidil 2% for Men and Women

Active ingredient

Minoxidil 2% w/v

Purpose

Hair Regrowth Treatment

Use

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

Warnings

For external use only. Flammable: Keep away from fire or flame.

Do not use if

  • 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. Minoxidil Topical Solution 2% is not intended for frontal baldness or receding hairline.
  • You have no family history of hair loss.
  • You 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 or 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. Results may occur at 2 months with twice daily 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 everyone.

Stop use and ask a doctor if you have

  • 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 immediately. (1-800-222-1222)

Directions

  • Apply one mL 2 times daily directly onto the scalp in the hair loss area.
  • Using more or more often will not improve results.
  • Continued use is necessary or hair loss will resume.

Other Information

  • See hair loss picture on the side of this carton.
  • Before use, read all information on carton and printed insert.
  • 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 Minoxidil Topical Solution 2%.
  • In clinical studies with mostly caucasian women aged 18-45 years with mild to no moderate degrees of hair loss, the following respone to Minoxidil Topical Solution 2% was reported: 19% of women reported moderate hair regrowth after using Minoxidil Topical Solution 2% for 8 months. This compares with 7% of women reporting moderate hair regrowth and 33% reporting minimal regrowth after using the placebo, the liquid without minoxidil in it, for 8 months.

Store at 20-25C (68-77F). Keep tightly closed.

Inactive Ingredients:

Alcohol, Propylene Glycol, Purified water

Questions or Comments?

1-800-237-7157

Distributed By:

Loesch Laboratory Consultants, Inc.

4311 South Dr., Houston

Texas 77053-4820, USA

800-231-7157

M-F 8 am - 5 pm CST

www.loeschlab.com

Principal Display Panel

Loesch® Hair Regrowth Formula

Regular-Strength Minoxidil 2% for Men and Women

One Month Supply

60 ml (2.0 fl.oz.)

NDC: 25280-007-42

Carton.jpgCarton Label.jpgLabel

LOESCH HAIR REGROWTH FORMULA  UNSCENTED TOPICAL SOLUTION REGULAR-STRENGTH FOR MEN AND WOMEN
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 25280-007(NDC: 49035-202)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 25280-007-421 in 1 PACKAGE
160 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07535708/11/2014
Labeler - Loesch Laboratory Consultants, Inc. (026619510)
Registrant - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356relabel(25280-007)

Revised: 8/2014
 
Loesch Laboratory Consultants, Inc.


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