Active Ingredients
Ketoconazole 1% w/w
Poagci Ketoconazole Vcp-kad001
FDA Label NDC 84745-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vince (guangzhou) Cosmetics Co., Ltd. for the product Poagci Ketoconazole Vcp-kad001 (NDC 84745-002). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-dandruff shampoo
Uses
controls flaking, scaling and itching associated with dandruff
Warnings
For external use only
Do Not Use
on scalp that is broken or inflamed
if you are allergic to ingredients in this produc
When Using This Product
avoid contact with eyes
if product gets into eyes, rinse thoroughly with water
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.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Adults And Children 12 Years And Over
wet hair thoroughly
apply shampoo, generously lather, rinse thoroughly.
Repeat use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruf
Children Under 12 Years
ask a doctor
Other Information
store at 20°C to 25°C (68°F-77°F)
see package for lot number and expiration date
Inactive Ingredients
Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Sodium Lauryl Sulfate, Dimethicone, Dimethiconol, Disodium Laureth Sulfosuccinate, Zinc Pyrithione, Phenoxyethanol, Fragrance, Sodium Cocoyl Alaninate, Caprylyl/Capryl Glucoside, Guar Hydroxypropyltrimonium Chloride, Salicylic Acid, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyquaternium-67, Glycerin, Sodium Hydroxide, Cetrimonium Chloride, Benzoic Acid, Acrylamidopropyltrimonium Chloride/Acrylamide Copolymer, Piroctone Olamine, Laureth-23, Tea-Dodecylbenzenesulfonate, Sodium Polynaphthalenesulfonate, DMDM Hydantoin, Sodium Benzoate, Cellulose Gum, Ethylhexylglycerin, CI 16255
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