Otc - Active Ingredient
Ketoconazole 1%
Gembooxt Ketoconazole 1% Medicated Shampoos Liquid
FDA Label NDC 76986-025
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 Gembooxt Ketoconazole 1% Medicated Shampoos (NDC 76986-025). 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 - purpose, indications & usage, warnings, otc - 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
Otc - Purpose
Anti-dandruff shampoo
Indications & Usage
Controls flaking, scaling and itching associated with dandruff
Warnings
For external use only.
Otc - Do Not Use
on scalp that is broken or inflamed.
if you are allergic to ingredients in this product.
Otc - When Using
When using this products. Avoid contact with eyes. lf contact occurs, rinse thoroughly with water.
If pregnant or breast-feeding, ask a doctor before use.
Otc - Stop Use
rash appears.
condition worsens or does not improve in 2-4 weeks.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
For adults and children 12 years and older:
1. Wet hair thoroughly.
2. Apply shampoo, generously lather, rinse thoroughly. Repeat.
3. Use every 3-4 days for up to 8 weeks or as directed by a doctor.Then use only as needed to control dandruff.
Children under 12 years: Ask a doctor.
Inactive Ingredient
WATER
SODIUM LAUROYL SARCOSINATE
COCAMIDOPROPYL BETAINE
WATER
PARFUM
GLYCERYL CAPRYLATE
GLYCERYL LAURATE
PHENOXYETHANOL
WATER
LAURYL LACTATE
CITRIC ACID
POLYQUATERNIUM-10
DISODIUM EDTA
HYDROLYZED RHODOPHYCEAE EXTRACT
BUTYLENE GLYCOL
1,2-HEXANEDIOL
PENTYLENE GLYCOL
PROPANEDIOL
CAPRYLHYDROXAMIC ACID
ETHYLHEXYLGLYCERIN
BIOTIN
POTASSIUM HYDROXIDE
Package Label.Principal Display Panel
Label2 (Label2)
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