Otc - Active Ingredient
Ketoconazole 1%
Anti-fungal Shampoo
FDA Label NDC 87255-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Mengyue Technology Co., Ltd. for the product Anti-fungal (NDC 87255-008). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-Fungal shampoo
Uses
controls flaking, scaling and itching associated with dandruff
Warnings
For external use only
Do Not Use
- on scalp that is broken or inflamed
- if you are allergic to ingredients in this product
When Using This Product
- avoid contact with eyes
- if product gets into eyes,rinse thoroughly with water
Stop Use And Ask A Doctor If
- rash appears
- condition worsens or does not improve in 2-4 weeks
Otc - Keep Out Of Reach Of Children
If pregnant or breast-feeding, ask a doctor before use.
Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away.
Directions
adults and children 12 years and over
- 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
children under 12 years
- ask a doctor
Other Information
- store at 20℃ to 25℃(68°F-77°F)
- see top panel for lot number and expiration date
Inactive Ingredients
blue l, citric acid, cocamide MEA. mentha Piperita Oil.glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7.sodium benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, tetrasodium EDTA, water
Package Label.Principal Display Panel
87255-008-01 (87255 008 01)
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