FDA Label for Loesch Hair Regrowth Formula Unscented Topical Solution Regular-strength 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.

Otc - Ask Doctor

​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.

Otc - Pregnancy Or Breast Feeding

​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.

Storage And Handling

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

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