Active Ingredient(S)
Ketoconazole 1%
1% Ketoconazole Anti Dandruff
FDA Label NDC 84558-005
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 Yusong Fine Chemicls Co., Ltd for the product 1% Ketoconazole Anti Dandruff (NDC 84558-005). 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
Anti-dandruff shampoo
Use
controls flaking, scaling and itching from dandruff
Warnings
For external use only
Do Not Use
on scalp that is broken or inflamed
if there is a known sensitivity to any of the ingredients
Otc - When Using
avoid contact with eyes
in case of such contact, rinse well with water
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. If swallowed, get medical help or
contact a Poison Control Center right away,
Directions
adults and children 12 years and over：①wet hair thoroughly ②apply shampoo, generously lather, rinse thoroughly. Repeat
③use 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
Other Information
①store at 20°C to 25°C (68*F-77°F)
②see bottom panel for expiration date
Inactive Ingredients
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide Dea, Dimethicone, Sodium Chloride, Glycol Distearate,
Amino BispropyI Dimethicone, Fragrance, Polyquaternium-10, Carbomer, Azelaic Acid, L aurtrimonium Chloride, Guar
Hydroxypropyltrimonium Chloride, Methylisothiazolinone, Citric Acid, Coco/Oleamidopropyl Betaine, Dodecylbenzene Sulfonic
Acid, C12-15 Pareth-3, Hydroxypropyltrimonium Hydrolyzed Collagen, Triethanolamine, Phenoxyethanol, AO1
Package Label - Principal Display Panel
Undefined (Label)
Undefined (Label1)
Undefined (Label2)
Undefined (Label3)
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