Otc - Active Ingredient
Active ingredient
Purpose
Ketoconazole 1% w/w....Anti-dandruff shampoo
Anti-dandruff Shampoo
FDA Label NDC 85593-036
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 85593-036). 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, indications & usage, 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
Relieves ItchingControls FlakingScalp Clarifying
Seborrheic Dermatitis Care
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Warnings
For external use only. Avoid contact witheyes. Ifcontact occurs, rinse thoroughlywithwater.
Dosage & Administration
Use every 3-4 days for up to 8 weeks. Afterthat, use only asneeded to control dandruff.
Indications & Usage
For best results, follow these steps
carefully:lukewarm water.
1.Wet hair and scalp thoroughly with
2.Applya sufficient amount of shampooto
generate a rich lather.3.Gently massage the lather into your scalp
and hair.
4.Leave the lather on the scalp for 3-5medication to work effectively.5.Rinse thoroughly with water.
minutes. This contact time is crucialfor the
Inactive Ingredient
Aqua, Sodium Laureth Sulfate, CocamideDEA, Sodium Chloride, CocamidopropylBetaine, Ammonium Lauryl Sulfate,Fragrance, Phenoxyethanol, PEG-7 GlycerylCocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl GuarHydroxypropyltrimonium Chloride, C12-13Pareth Lactate, CitricAcid, C11-15 Pareth-9,Trideceth-12, Sodium Benzoate.
Package Label.Principal Display Panel
Labeling (85593 036 01)
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