Active Ingredient
Minoxidil 5.0% w/v
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Olivita 5% Minoxidil (NDC 83818-028). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5.0% w/v
Hair regrowth treatment for men
to regrow hair on the top of the scalp (vertex only, see picture on side of box)
For external use only. For use by men only.
Flammable: Keep away from fire or flame
▪ you are a woman
▪ your amount of hair loss is different than that shown on the side of this box or your hair loss is on the front of the scalp. 5% Minoxidil Topical Solution is not intended for frontal baldness or receding hairline.
▪ you have no family history of hair loss
▪ your hair loss is sudden and/or patchy
▪ 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 medications on the scalp
▪ 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 men, you may need to use this product for at least 4 months before seeing results.
▪ the amount of hair regrowth is different for each person. This product will not work for all men.
▪ 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
▪ 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 breastfeeding.
If swallowed, get medical help or contact a Poison Control Center immediately.
▪ apply one ml. (6 sprays) 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
▪ see hair loss pictures on side of this box
▪ before use, read all information on carton and enclosed insert
▪ keep carton, it contains important information
▪ hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution 5% for men
▪ in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair regrowth than Minoxidil Topical Solution 2%
▪ store at controlled room temperature 20° to 25°C (68° to 77°F)
alcohol, propylene glycol, purified water
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