Active Ingredient
HEXAMIDINE DIISETHIONATE 0.1%
Pharmbanner Anti-fungal Shampoo. Shampoo
FDA Label NDC 83818-015
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 Xinxin Yunhai Technology Co., Ltd. for the product Pharmbanner Anti-fungal Shampoo. (NDC 83818-015). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
▪ Helps relieve symptoms of fungal and inflammatory skin conditions, including:
– Folliculitis
– Dandruff
– Seborrheic dermatitis
– Tinea versicolor
– Jock itch
▪ Reduces itching, flaking, redness, and irritation
Warnings
For external use only
Do Not Use
▪ On broken or severely damaged skin without consulting a doctor
When Using
▪ Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop Use
▪ Irritation or rash occurs and lasts
Ask Doctor
▪ A known allergy to any of the listed ingredients
▪ Severe skin conditions not diagnosed by a doctor
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
▪ Apply a small amount to the affected area and lather gently.
▪ Leave on for 2–5 minutes before rinsing.
▪ Use 3 to 5 times per week or as directed by a doctor.
▪ For best results, use consistently.
Other Information
▪ Store in a cool, dry place away from direct sunlight
▪ Do not use if seal is broken or missing
Inactive Ingredients
Aqua (Water), Sodium Laureth Sulfate, Urea, Cetearyl Alcohol, Dimethicone, Cocamidopropyl Betaine, C12-15 Pareth-3, Iodopropynyl Butylcarbamate, Glycol Distearate, Glycol Stearate, Sodium Lauroamphoacetate, Dihydrogenated Tallow Phthalic Acid Amide, Menthol, Piroctone Olamine, Glyceryl, Guar Hydroxypropyltrimonium Chloride, Sodium Chloride, Nymphaea Alba Flower Extract, Coptis Chinensis Extract, Rheum Officinale Extract, Polygonum Multiflorum Root Extract, Houttuynia Cordata Extract, Foeniculum Vulgare Extract, Taraxacum Mongolicum Extract, Panax Ginseng Root Extract, Citric Acid, Disodium EDTA, Salicylic Acid, Melaleuca Alternifolia (Tea Tree) Oil.
Questions
Email us at: [email protected]
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