Otc - Active Ingredient
Active ingredient
Ketoconazole 1%
Purpose Anti-dandruff
Anti Dandruff Shampoo
FDA Label NDC 85593-121
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 Chuanma International Trading Co.,ltd. for the product Anti Dandruff (NDC 85593-121). 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, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, indications & usage, packeg, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps control flaking and itching associated with dandruff
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical
help orcontact a Poison Control Center right away.
Warnings
Stop use and ask a doctor if
rash occurs condition worsens or does not improve after
regular use as directed
aIf pregnant or breast-feeding, ask a doctor before use.
Keep out of reach of children. If swallowed, get medical
help or contacta Poison Control Centerright away.
Dosage & Administration
Repeat.use every 3-4 days forup to 8 weeks or as directedby a doctor.
Inactive Ingredient
Inactive ingredients
Aqua, Sodium Laureth Sulfate, Cocamide DEA, SodiumChloride, Cocamidopropyl Betaine, Ammonium LaurylSulfate, Polyquaternium-10, Fragrance, Phenoxyethanol,PEG-7 Glyceryl Cocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl Guar Hydroxypropyltrimonium Chloride,C12-13 Pareth-3, Lactate, Citric Acid, C11-15 Pareth-9,Trideceth-12, Sodium Benzoate.
Indications & Usage
Directions
adults and children 12 years and older: wet hairthoroughly,apply shampoo, generously lather, rinsethoroughly. Repeat.use every 3-4 days for up to 8 weeks or as directedby a doctor. Then use only as needed to controldandruff.
Packeg
Labeling (230ml 85593 121)
Labeling (230ml 85593 121)
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