Active Ingredient(S)
Minoxidil 5% w/v
Glemme 5% Minoxidil Hair Regrowth Cream
FDA Label NDC 84148-016
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 Glemme 5% Minoxidil Hair Regrowth Cream (NDC 84148-016). 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
Use(s) to regrow hair
Warnings
For external use only.
Do Not Use
·Your hair loss is sudden, uncertain or patchy.
.You are pregnant or breastfeeding.
.You are under 18 years of age.
.Your scalp is red, inflamed, infected, irritated, or painful.
·You use other medicines on the scalp.
Otc - When Using
. Do not apply on other parts of the body.
.Avoid contact with eyes. If contact occurs, rinse thoroughly with cool water.
Otc - Stop Use
Discontinue use if redness or irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Apply right amount of hair growth cream on the hair loss
area, gently massage the scalp with your fingers until the
product is fully absorbed.
Other Information
Store it in a cool, dry environment, away from heat, moisture, and direct light.
Inactive Ingredients
Water, Glycerin, Cetearyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil，Trehalose, Aloe Barbadensis Leaf
Water, Panthenol, Ceteary| Olivate, Sorbitan Olivate，Biotin, Caffeine, Hydrolyzed Keratin, Tocophery| Acetate,
Rosmarinus Officinalis(Rosemary) Leaf Oil, Phenoxyethanol,Sodium Hydroxide, Ethylhexylglycerin.
Package Label - Principal Display Panel
Undefined (Label)
* Please review the disclaimer below.
