Otc - Active Ingredient
Ketoconazole 1% ..
PurposeAnti-dandruff
Anti-dandruff Shampoo
FDA Label NDC 85593-129
7 label sections · Submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. · 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 85593-129). 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, 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
controls flaking, scaling and itching asso-ciated with dandruff
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical helpor contact a Poison Control Center right away.
Warnings
Warnings
For external use only
Dosage & Administration
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.
Inactive Ingredient
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
Stop use and ask a doctor if
rash appears or if condition worsens or does not improve in 2to4weeks
* Please review the disclaimer below.
