Active Ingredient(S)
Minoxidil 5% w/v
Flinkye 5% Minoxidil Hair Growth Shampoo
FDA Label NDC 84148-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ariel Biotech Co., Ltd. for the product Flinkye 5% Minoxidil Hair Growth (NDC 84148-017). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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 scalp
Warnings
For external use only.
Do Not Use
.Your hair loss is associated with childbirth.
.You have sudden or unexplained hair loss.
. You are under 18 years of age.
.Your scalp is red, inflamed, infected, irritated, or painful.
·You are using other topical medicines on your scalp.
Otc - When Using
. Do not apply to other parts of the body.
. Some people may experience changes in hair color and/or texture.
.Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
.It takes time to regrow hair. Results may occur at 3 months.For
some people, you may need to use this product for at least 6
months before you see results.
Otc - Stop Use
Discontinue use if redness or irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
1. Thoroughly wet hair and scalp with warm water. Use every 1 to 3 days.
2. Apply a generous amount of shampoo to your hair.
3. Gently massage into a rich lather for 3-5 minutes. Spend extra time on areas of concern.
4. Rinse thoroughly with warm water.
Other Information
.Store at controlled room temperature20°C to 25°C (68F to 77°F).
. Contents under pressure. Do not puncture or incinerate the container.
. Do not expose to heat or store at temperatures above 49°C (120°F).
Inactive Ingredients
Aqua (Water), Sodium C14-16 Olefin Sulfonate,Cocamidopropyl Betaine, Lauryl Glucoside,CocamideMIPA, Glycerin, Propylene
Glycol, Biotin, Panthenol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Polyquaternium-10, PEG-7 Glyceryl Cocoate, Citric Acid,
Phenoxyethanol, Ethylhexylglycerin, Fragrance (Parfum), Disodium EDTA.
Package Label - Principal Display Panel
Undefined (Label)
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