FDA Label for Remixdil Hair Regrowth Treatment For Women
View Indications, Usage & Precautions
Remixdil Hair Regrowth Treatment For Women Product Label
The following document was submitted to the FDA by the labeler of this product Rida 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
Use
Use to regrow hair on the scalp
Otc - Purpose
Hair regrowth treatment
Warnings
For external use only.
Flamable: Keep away from fire of flame.
Otc - 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
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 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 everyone.
Otc - 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 or feet swell
- Scalp irritation or redness occurs
- You get unwanted facial hair growth
- 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 right away.
Directions
- apply 1mL 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
Other 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 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 oto 25 oC (68 oto 77 oF)
Inactive Ingredient
Alcohol, Propylene Glycol, Purified Water
Other
Questions or comments? 1-800-641-8871
Visit website at www.rida-hair.com
Product Label
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