Otc - Active Ingredient
Minoxidil 5%
5% Minoxidil Hair Regrowth Treatment
FDA Label NDC 83648-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Baixingchen Technology Co., Ltd. for the product 5% Minoxidil Hair Regrowth Treatment (NDC 83648-002). 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 otc - active ingredient, otc - ask doctor, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor
Ask a Doctor before use if you
have Heart disease.
Warnings
Warnings
-For external use only.
-Keep away from fire and flame.
-Avoid contact with eyes.
Otc - Do Not Use
Do not use
-You have no family history of hair loss,hair loss is sudden and/orpatchy.
-You do not know the reason for your hair loss.
-You are under 18 years of age.
Do not use it on babies and children.
-Your scalp is red,inflamed, infect-edirritated,or painful.
-You use other medicines on the scalp.
Otc - When Using
When using
-Do not apply on other parts of the body.
-void contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water.
-It takes time to regrow hair. You may need to use this product 2 times a day for a least 4 months before you see results, The amount of hair regrowth is different for each person
Otc - Stop Use
Stop use and ask doctor if
-chest pain,rapid heart beat,faintness,or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs
-May be harmful 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. (1-800-222-1222)
Otc - Purpose
Hair Regrowth Treatment
Other Safety Information
Other information
-Before use, read all information on the carton.
-Store at controlled room temperature 20 to 25 ℃ (68 to 77°F)
Dosage & Administration
Directions
-Apply 1ml (7 Sprays) twice a day.
Once in the morning and another time in the evening before bed.
-Spray directly on top of the scalp in the area to be treated.
-Using more than directed or more often will not improve results.
-Continued use is necessary to increase and then maintain your hair regrowth.
-Discontinuing use may result in hair loss.
Inactive Ingredient
Inactive ingredients
Propylene Glycol, Ethyl Alcohol, Aqua.
Indications & Usage
Use to regrow hair on the top of the scalp.
* Please review the disclaimer below.
