Otc - Active Ingredient
ketoconazole 1%
Anti Dandruff Shampoo
FDA Label NDC 85593-033
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 85593-033). 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, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti Dandruff
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Warnings
For external use only
Indications & Usage
For best results, follow these stepscarefully:1.Wet hair and scalp thoroughly with
lukewarm water.
2.Apply a sufficient amount of shampoo to
generate a rich lather.
3.Gently massage the lather into your scalp
and hair.4.Leavethe latheron the scalp for3-5minutes. This contact time is crucialforthemedication to work effectively.5.Rinse thoroughly with water.
Dosage & Administration
Use every 3-4 days for up to 8 weeks. Afterthat, use only as needed to control dandruff.
Inactive Ingredient
Aqua, Sodium Laureth Sulfate, Cocamide DEA,Sodium Chloride, Cocamidopropyl Betaine,Ammonium LaurylSulfate, Ketoconazole,Fragrance, Phenoxyethanol, PEG-7 GlycerylCocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl Guar HydroxypropyltrimoniumChloride, C12-13 Pareth Lactate, CitricAcid, C11-15 Pareth-9, Trideceth-12, Sodium Benzoate.
Package Label.Principal Display Panel
Labeling (85593 033 01)
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