VITADIL-2A  - minoxidil solution 
Guthy-Renker Hair Solution LLC

----------

Women's Vitadil -2A (Minaxidil Topical Solution USP. 2% for Women) Important information about Women's Vitadil-2A
Save leaflet for future reference
• Hair regrowth treatment
• Previously available only by prescription
Over 30 million American women experience hair thinning or hair loss, so you are not alone. Women's Vitadil-2A contains the only ingredient that is medically proven effective to help regrow hair in women. Please read this leaflet carefully. It win help you understand how to use Women's Vitadil-2A and what to expect from its use. If you have any questions after reading this leaflet or anytime while using Women's Vitadil-2A, you should ask your health care professional or contact GR Hair Solutions LLC at 1-800-203-2719.
What is Women's Vitadil-2A?
Women's Vitadil-2A is a colorless liquid medication for use on the top of the scalp to help regrow hair.
Who may use Women's Vitadil-2A?
Women's VitadiI-2A may be appropriate for you if you are an adult who is at least 18 years  old and experiencing gradually thinning hair or gradual hair loss on the top of the head. The common hereditary thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss. Women's Vitadil-2A is for general thinning of hair on the top of the scalp as shown below. Women's Vitadil-2A has been shown to regrow hair in women with the degrees of hair loss shown. If women have more hair loss than shown, Women's Vitadil-2A may not work. Many of those experiencing hair loss have other family members with gradual thinning hair or hair loss. If you have no family history of gradual thinning hair or gradual hair loss or
your hair loss is patchy, see your doctor.
Who should NOT use Women's Vitadil-2A?
Women's Vitadil-2A will not prevent or improve hair loss related to pregnancy, the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; excessive vitamin A intake), the recently discontinued use of birth control pills, low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp.
Also, Women's Vitadil loss due to:
Do not use Woman's Vitadil-2A if hair loss is patchy.
You should ask your if you are unsure of the cause of your hair loss.
 Will Women's Vitadil-2A ,work for me?
 The amount of hair regrowth is different for each person. Not everyone will respond to Women's Vitadil-2A. The response to Women's Vitadil-2A cannot be predicted. No one will be able to grow back all their hair. In clinical studies of mostly white women age 18-45 years with mild to moderate degrees of hair loss, the following response to Minoxidil topical solution 2% was reported.
Diagram
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).
Chart
Can Women's Vitadil-2A be used to prevent hair loss?
We do not know if Women's Vitadil-2A will prevent hair loss.
How soon can I expect results from using Women's Vitadil-2A?
Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with Women's Vitadil-2A also takes time. Generally new hair growth is slow for a Women's Vitadil-2A user.Continued use of 2 times a day for at least 4 months is usually needed before you notice hair regrowth. If you do not see hair regrowth in 4 months, stop using Women's Vitadil-2A and see your doctor. When you first begin to use Women's Vitadil-2A, your hair loss may continue for up to 2 weeks. This hair loss is temporary. If you continue to lose hair after two weeks, see your doctor.
If Women's Vitadil-2A is working, what will the  hair look like?
At first, hair growth may be soft, downy, colorless hairs. After further use, the new hairs should be the same color and thickness as the other hairs on your scalp.
How long do I need to use Women's Vitadil-2A?
If you respond to Women's Vitadil-2A, you need to use it 2 times a day to keep and continue the hair regrowth. Up to 8 months of usage may be
needed to see your best results from Women's Vitildil-2A.
What happens if I completely stop using Women's Vitadil-2A? Willi keep the new hair?
Continuous use of Women's Vitadil-2A is needed to maintain hair regrowth. If you stop using Women's Vitadil-2A, the normal hair loss process will start again. You will lose your newly regrown hair in 3 to 4 months. What is the dosage of Women's Vitadil-2A? You should apply a dose (1 mL) of Women's Vitadil-2A directly onto the scalp in the hair loss area two times a day; for example, once in the morning and once at night. Each bottle should last about one month, if used as directed. Please refer to the Directions for Use section of this leaflet.
What if I miss a dose or forget to use Women's Vitadil-2A?
If you miss one or two daily doses of Women's Vitadil-2A, just contirlUe with your next dose. You should not make up for missed doses.
Can I use Women's Vitadil-2A more than two times a day? Will it work faster, better?
No. Women's Vitadil-2A will not work faster or better if used more than two times a dily. Studies have been carefully conducted to determine the correct amount of Women's Vitadil-2A needed to get the best results. More frequent use or larger doses have not been shown to speed up hair growth and may increase your chance of side effects.
What are the most common side effects with Women's Vitadil-2A?
The mqst common side effects are itching and other skin irritations of the treated area of the scalp. Women's Vitadil-2A contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If Women's Vitadil-2A accidentally gets into these areas, rinse with large amounts of cool tap water.Contact your doctor if irritation persists.
What kind of shampoo should I use with Women's Vitadil-2A?
If you wash your scalp before applying Women's Vitadil-2A, use a mild shampoo.
Can I use hair sprays, mousses, conditioners, gel, etc?
Yes. There is no reason to change your usual hair care routine when using Women's Vitildil-2A. However, you should apply Women's Vitadil-2A
first and wait for it to dry before applying your styling aids.
Can I have my hair colored or permed or use hair relaxers while using Women's Vitadil-2A?
Yes. We have no information that these treatments change the effect of Women's Vitadil-2A. However, to avoid possible scalp irritation, you should make sure all of the Women's Vitadil-2A has been washed off the hair and scalp before using these chemicals.
Can I apply Women's Vitadil-2A and wash my hair an hour later?
No. For Women's Vitadil-2A to work best, you should allow Women's Vitadil-2A to remain on the scalp for about 4 hours before washing.
Can I go swimming or out in the rain?
Yes. Avoid washing off the Women's Vitadil-2A. If possible, apply Women's Vitadil-2A to a dry scalp after swimming, or wait about 4 hours after application before going swimming. Do not let your scalp get wet from the rain after applying Women's Vitadil-2A.
Can Women's Vitadil-2A produce unwanted hair?
Although unwanted hair growth has been reported on the face and on other parts of the body, such reports have been infrequent. The unwanted hair growth may be caused by the transfer of Women's Vitadil-2A to areas other than the scalp, or by absorption into the circulatory system of low levels of the active ingredient, or by a medical condition not related to the use of Women's Vitadil-2A. If you experience unwanted hair, discontinue using Women's Vitadil-2A and see your doctor for recommendations about appropriate treatment. After stopping use of Women's Vitadil-2A. the unwanted hair, if caused by the use of Women's Vitadil-2A, should go away over time. You can take steps to decrease the chances of unwanted hear grows: 1.).Iimit the application of Women's Vitadil-2A only to the scalp, 2) if you use your hands to apply Women's Vitadil-2A, wash your hands thoroughly afterwards, and 3) allow sufficient drying time (usually 2 to 4 hours before going to bed) after your nighttime application of Women's Vitadil-2A.
Can I use Women's Vitadil-2A for baldness or hair loss in babies or children?
No. Women's Vitadil-2A must not be used to treat baldness or hair loss in babies or children.
Are there any special warnings about the use of Women's Vitadil-2A?
For external use only
Flammable: Keep away from fire or flame

Do not use if
Ask a doctor before use if you have heart disease.
When using this product
• Do not apply "on other parts other 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 arid/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 everyone
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 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 right away.
What factors may increase the risk of serious side effects with Women's Vitadil-2A?
Women's Vitadil-2A should be applied only to the scalp. The risk of side effects may be greater when Women's Vitadil-2A is applied to other
parts of the body.
Directions for Use
1. Remove the cap. To remove, push down and turn in direction of the arrows on the cap.
2. Part your hair in the area of hair thinning or loss. Follow the instructions below for using the dropper applicator and apply one mL 2 times a day direct.ly onto the scalp in the hair loss area. Do not use more. Spread the liquid evenly over the hair loss area. If you use your fingers, wash hands with soap and water immediately. Each bottle should last about one month if used as directed. Use a mild shampoo if you wash your scalp before
applying Women's Vitadil-2A.
Using the Dropper Applicator
1. Squeeze the rubber bulb and insert the dropper into the bottle. Release the bulb, allowing the dropper to fill to the 1 mL line. If the level of the solution is above the 1 mL line, squeeze the extra amount back into the bottle.
2. Next, place the tip of the dropper near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. To prevent the solution from runnung off the scalp, apply a small amount at a time.
3. After each use attach the dropper to the bottle to make it child-resistant by turning it clockwise until tightly closed.
If you have any other questions, ask your health care professional or call GR Hair Solutions LLC at 1-800-203-2719.
Store at controlled room temperature 20° - 25° C (68° - 77° F). Keep tightly closed.
Save this leaflet for future reference.
Distributed by:
GR Hair Solutions LLC
Palm Desert, CA 92260
800-203-2719

Minoxidil 2% w/v

Purpose..................Hair regrowth treatment

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

to regrow hair on the top of the scalp

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

• 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

alcohol 60% v/v, propylene glycol, 20% v/v, purified water

Label
U Carton
U carton
U carton
U carton

VITADIL-2A 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-934
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Minoxidil (Minoxidil) Minoxidil2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Propylene Glycol 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:11410-934-0221 CARTON ( CARTON) in 1 CASEcontains a CARTON
12 CYLINDER ( CYLINDER) in 1 CARTONThis package is contained within the CASE (11410-934-02) and contains a CYLINDER
156.7 g in 1 CYLINDERThis package is contained within a CARTON and a CASE (11410-934-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07817605/01/200810/20/2010

Labeler - Guthy-Renker Hair Solution LLC (608315453)
Registrant - Harmony Labs, Inc. (105803274)
Establishment
NameAddressID/FEIOperations
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 01/2012 Guthy-Renker Hair Solution LLC