Otc - Keep Out Of Reach Of Children
STORAGE
Store at room temperature away frommoisture and direct sunlight.
Keep the bottle tightlyclosed.
Keep out of reach of children and pets.
Anti Dandruff Liquid
FDA Label NDC 74458-157
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 Yilong Cosmetics.,ltd for the product Anti Dandruff (NDC 74458-157). 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 - keep out of reach of children, indications & usage, warnings, inactive ingredient, recent major changes, otc - purpose, dosage & administration, 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
Indications & Usage
DIRECTIONS FOR USE
For best results, follow these stepscarefully:
1.Wet hair and scalp thoroughly with
lukewarm water.
2.Applya sufficient amountof shampoo to
generate a rich lather.
3.Gently massage the lather into your scalp
and hair.
4.Leave the lather on the scalpfor3-5minutes. This contact time is crucialforthemedication to work effectively.5.Rinse thoroughly with water.
Warnings
PRECAUTIONS
For externaluse only.Avoid contact witheyes. Ifcontactoccurs, rinse thoroughlywithwater.Stop use and consult a doctor if youexperience severe irritation, rash, oranysigns of an allergic reaction (e.g., swelling,dizziness, trouble breathing). Before usingthis shampoo if you have known allergiesto ketoconazole or any other ingredients.
Inactive Ingredient
Aqua
Sodium Laureth Sulfate
Cocamide DEA
Sodium Chloride
Cocamidopropyl Betaine
Ammonium Lauryl Sulfate
Fragrance
Phenoxyethanol
PEG-7 Glyceryl Cocoate
Bis-Aminopropyl Dimethicone
Hydroxypropyl Guar
Hydroxypropyltrimonium Chloride
C12-13 Pareth Lactate
Citric Acid
C11-15 Pareth-9
Trideceth-12
Sodium Benzoate
Recent Major Changes
Use every 3-4 days for up to 8 weeks. Afterthat, use only as needed to control dandruff.
Otc - Purpose
Ketoconazole 1% w/w....Anti-dandruff shampoo
Dosage & Administration
Use every 3-4 days for up to 8 weeks. Afterthat, use only as needed to control dandruff.
Package Label.Principal Display Panel
1 (55c46b50 4426 E3c8 E063 6294a90ad76b)
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