Otc - Active Ingredient
Active ingredient
Ketoconazole 1%.
PurposeAnti-dandruff
Anti Dandruff Shampoo
FDA Label NDC 85593-122
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 85593-122). 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
Use
controls flaking, scaling and itching asso-
ciated withdandruff
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
Do not use
on scalp that is broken or inflamed
on children under 12 years of age unless directed by a doctor
Dosage & Administration
Repeat. use every 3-4 days for up to 8 week
Indications & Usage
Directions
adults and children 12 years and older: 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
dandruff.
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.
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