NUTRASTIM HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil solution

Nutrastim by

Drug Labeling and Warnings

Nutrastim by is a Otc medication manufactured, distributed, or labeled by Pulsaderm Llc, Chemolee Lab Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Nutrastim Hair Regrowth Treatment Topical Solution USP, 2% For Women Drug Facts Panel

Active ingredient:

Minoxidil 2% w/v

Purpose

To regrow hair on the scalp.

Warnings

For external use only.

For use by women only.

Flammable. Keep away from fire or flame.

Do not use if...

• Your degree of hair loss is different than that shown on the 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 child birth.
• 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.

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.
• It takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some women, you may need to use this product for at least 4 months before you see results.
• The amount of hair regrowth is different with each person. This product will not work for all women.

Stop use and call your 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 4 months.

PREGNANCY OR BREAST FEEDING

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

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 1 ml, 2 times daily directly with the dropper 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

• Before use see hair loss pictures on side of this box.
• Keep the box, it contains important information.
• In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution was 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth: 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
• Store at 20° to 25° C (68° to 77° F).

Keep tightly closed.

Inactive ingredients:

Alcohol, propylene glycol, purified water

Questions?

Call us at 1-844-892-8578

Visit nutrastimhair.com

for more information about hair thinning, visit

nutrastimhair.com/women-education/

Nutrastim Hair Regrowth Treatment Topical Solution USP, 2% For Women Two Month Supply

NutrastimWFrontBox.jpg NutrastimWBackBox.jpg

INGREDIENTS AND APPEARANCE

NUTRASTIM  HAIR REGROWTH TREATMENT FOR WOMEN
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71177-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71177-002-02	2 in 1 CARTON	02/14/2017
1	NDC: 71177-002-01	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075598	02/14/2017

Labeler - Pulsaderm Llc (080429881)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(71177-002)