SHAPRIERO 2% HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil solution

Shapriero 2% Hair Regrowth Treatment for Women by

Drug Labeling and Warnings

Shapriero 2% Hair Regrowth Treatment for Women by is a Otc medication manufactured, distributed, or labeled by CONVERSION LABS PR, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 2% w/v

USE

Use to regrow hair on the scalp

PURPOSE

Hair regrowth treatment

WARNINGS

For external use only.

Flamable: Keep away from fire of flame.

DO NOT USE

Do not use if:

Your degree of hair loss is different than 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 childbirth
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 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 expereinced 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 for each person.

STOP USE

Stop use and ask a doctor if

• Chest pain, rapid heart beat, faintness, or dissiness occurs
• Sudden, unexplained weight gain occurs
• Your hands of feet swell
• Scalp irritation or redness occurs
• You do not see hair regrowth in 8 months

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, as a healthcare professional before use.

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.

DIRECTIONS

Apply 1 mL with dropper 2 times a day directly onto the scalp in the hair loss area
Using more or more ofthen will not improve results
Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

OTHER INFORMATION

• In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
• Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)

INACTIVE INGREDIENT

Alcohol, Propylene Glycol, Purified Water

QUESTIONS

Questions or Comments?

• 1-877-907-4047
• Visit Website www.shapiromd.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHAPRIERO 2% HAIR REGROWTH TREATMENT FOR WOMEN 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73277-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73277-002-01	1 in 1 BOX	07/28/2019
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078176	07/28/2019

Labeler - CONVERSION LABS PR, LLC (081274371)