Otc - Active Ingredient
KETOCONAZOLE 1%
Gemachlich Zuhause Ketoconazole 1% Anti-dandruff Shampoos Liquid
FDA Label NDC 87681-009
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 Xinhongda Trading Service Co., Ltd. for the product Gemachlich Zuhause Ketoconazole 1% Anti-dandruff Shampoos (NDC 87681-009). 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 shampoos
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.
If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if
rash appears.
condition worsens or does not improve in 2-4 weeks.
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center righta way.
Dosage & Administration
For adults and children 12 years and older:
1. Wet hair thoroughly.
2. Apply shampoos, 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
PARFUM
GLYCERYL CAPRYLATE
GLYCERYL LAURATE
PHENOXYETHANOL
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
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Label (Label)
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