Regenpure Precision Minoxidil

Regenpure Precision Minoxidil
SPL v1
SPL
SPL Set ID 4a113921-b2a9-42cc-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2017-03-04

Description

Minoxidil, 5% w/v (in each 1mL dose)

Purpose

Hair Regrowth Topical Treatment


Medication Information

Purpose

Hair Regrowth Topical Treatment

Description

Minoxidil, 5% w/v (in each 1mL dose)

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

Hair Regrowth Topical Treatment

Warnings:

• For external use only.

• For use by men only.

• Flammable: Keep away from fire or flame.

Directions:

• Apply 1 mL with sprayer (6 sprays) 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.

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. Minoxidil Topical Solution, 5% 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 medications on the scalp.

Active Ingredient

Minoxidil, 5% w/v (in each 1mL dose)

Package Labeling:

Other Information:

• See hair loss pictures on side of this carton.

• Before use, read all information on carton and enclosed booklet.

• 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 5%.

• In clinical studies with mostly white men age 18-45 years with moderate degrees of hair loss, Minoxidil Topical Solution, 5% provided more hair regrowth than Minoxidil Topical Solution, 2%.

• Store at USP controlled room temperature 20° to 25°C (68° to 77°F).

Inactive Ingredients:

• Alcohol 30% v/v, propylene glycol 50% v/v, purified water

Questions Or Comments?

• Call your health professional or Salonceuticals, Inc. at 1-877-706-8688, Monday—Friday: 9:00am—5:00pm (EST)

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 Doctor If:

• Side effects occur: You may report side effects to FDA at 1-800-FDA-1088 or to Salonceuticals, Inc. at 1-877-706-8688

• Chest pain, rapid heartbeat, faintness, or dizziness occurs.

• Sudden, unexplained weight gain occurs.

• Your hands or feet swell.

• Scalp irritation occurs, and continues or worsens.

• Unwanted facial hair growth occurs.

Ask A Doctor Before Use If 

YOU HAVE HEART DISEASE.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use
  • to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).
Purpose: (PURPOSE:)

Hair Regrowth Topical Treatment

Warnings: (WARNINGS:)

• For external use only.

• For use by men only.

• Flammable: Keep away from fire or flame.

Directions: (DIRECTIONS:)

• Apply 1 mL with sprayer (6 sprays) 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.

Do Not Use If: (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. Minoxidil Topical Solution, 5% 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 medications on the scalp.

Active Ingredient (ACTIVE INGREDIENT)

Minoxidil, 5% w/v (in each 1mL dose)

Package Labeling:

Other Information: (OTHER INFORMATION:)

• See hair loss pictures on side of this carton.

• Before use, read all information on carton and enclosed booklet.

• 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 5%.

• In clinical studies with mostly white men age 18-45 years with moderate degrees of hair loss, Minoxidil Topical Solution, 5% provided more hair regrowth than Minoxidil Topical Solution, 2%.

• Store at USP controlled room temperature 20° to 25°C (68° to 77°F).

Inactive Ingredients: (INACTIVE INGREDIENTS:)

• Alcohol 30% v/v, propylene glycol 50% v/v, purified water

Questions Or Comments? (QUESTIONS OR COMMENTS?)

• Call your health professional or Salonceuticals, Inc. at 1-877-706-8688, Monday—Friday: 9:00am—5:00pm (EST)

When Using This Product: (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 Doctor If: (STOP USE AND ASK DOCTOR IF:)

• Side effects occur: You may report side effects to FDA at 1-800-FDA-1088 or to Salonceuticals, Inc. at 1-877-706-8688

• Chest pain, rapid heartbeat, faintness, or dizziness occurs.

• Sudden, unexplained weight gain occurs.

• Your hands or feet swell.

• Scalp irritation occurs, and continues or worsens.

• Unwanted facial hair growth occurs.

Ask A Doctor Before Use If  (ASK A DOCTOR BEFORE USE IF )

YOU HAVE HEART DISEASE.

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.


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