Active Ingredient
MINOXIDIL (5%)
Gemachlich Zuhause Hair Growth Foam (men) Liquid
FDA Label NDC 76986-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Gemachlich Zuhause Hair Growth Foam (men) (NDC 76986-008). 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.
Label Section Quick Index
Purpose
Hair regrowth treatment
Use
To regrow hair on the top of the scalp .
Warnings
· For external use only.
· Keep away from fire and flame.
Do Not Use
Do not use if：
·you have no family history of hair loss. 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 it on babies and children.
·the scalp is red, inflamed, infected, irritated, or painful.
·you are using other medicines on your scalp.
When Using
When Using this product:
■ Do not apply on other parts of the body.
■ Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water.
■ lt takes time to regrow hair.
You may need to use this product once a day for at least 4 months before you see results.
Stop Use
Ask a doctor before use if you have HEART DISEASE. Stop Using and ask a 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.
· you get unwanted facial hair growth.
· you do not see hair regrowth in 4 months.
Ask Doctor
Ask a doctor before use if you have HEART DISEASE. Stop Using and ask a 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.
· you get unwanted facial hair growth.
· you do not see hair regrowth in 4 months.
Keep Out Of Reach Of Children
Keep out of reach of Children.
In case of accidental ingestion, get medical help or contact a poison control center immediately.
Directions
Directions
.Wash the scalp before use .
.Apply 2-3 pumps once daily to the affected scalp, then gently massage it in. For best results, leave the product on for at least 4 hours before washing hair .
Other Information
Other information
· If you are using other drugs, please consult your physician or pharmacist before using this product.
· Store in a dry place at 20~25°C (68~77°F).
Inactive Ingredients
PROPYLENE GLYCOL
WATER
Polysorbate 20
POLYSORBATE 20
DIMETHYL ISOSORBIDE
HYDROLYZED RHODOPHYCEAE EXTRACT
1,2-Hexanediol
Biotin
Caffeine
Rosmarinus Officinalis (Rosemary) Extract
Panax Ginseng Root Extract
Alcohol
Platycladus Orientalis Leaf Extract
Glyceryl Caprylate
Hydroxyacetophenone
Ethylhexylglycerin
Mentholum（Menthol）
Acetyl Tetrapeptide-2
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