FDA Label for Bosley Md Regular Strength For Women
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Bosley Md Regular Strength For Women Product Label
The following document was submitted to the FDA by the labeler of this product Scientific Hair Research, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Minoxidil 2% w/v
Otc - Purpose
Hair regrowth treatment
Use
Use to regrow hair on the top of the scalp (vertex only, see picture on side of box)
Warnings
For external use only.
Flamable: Keep away from fire of flame.
Otc - Do Not Use
Do not use if:
- Your amount 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
Otc - Ask Doctor
Ask a doctor before use if you have heart disease
Otc - When Using
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 re-grow hair. 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 women.
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
May be harmful if used when pregnant or breast-feeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
- Apply one mL (6 sprays) 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 Safety Information
- See hair loss pictures on the side of this carton
- Before use, read all information on carton and enclosed leaflet
- Keep the carton. It contains important information
- In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to Minoxidil Topical Solution 2% 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 o C (68 o to 77 oF)
Inactive Ingredient
Alcohol, Propylene Glycol, Purified Water
Otc - Questions
Questions or comments? Call your health professional or BosleyMD at 1(800)BOSLEY1
Package Label.Principal Display Panel
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