Otc - Active Ingredient
Salicylic Acid 0.5% and Zinc Pyrithione 0.25%
Kopa Haiku Seborrheic Dermatitis Face Cream
FDA Label NDC 87041-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trovina Co. Ltd for the product Kopa Haiku Seborrheic Dermatitis Face Cream (NDC 87041-005). 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, indications & usage, warnings, otc - do not use, other safety information, otc - stop use, 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
Keratolytic and Antifungal
Indications & Usage
A gentle antifungal face cream designed for daily care of sensitive skin prone to seborrheic dermatitis and psoriasis.
Warnings
For external use only.
Otc - Do Not Use
Do not use it on children under 3 years of age.
Other Safety Information
Avoid contact with the eyes.
Otc - Stop Use
Irritation occurs or if there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of ingestion, seek medical help or contact a Poison Control Center immediately.
Dosage & Administration
1. Apply a small amount to clean, dry facial skin, focusing on affected areas (forehead, brows, sides of nose). 2. Use twice daily or as directed by a healthcare professional. 3. Suitable for use under makeup.4. For external use only.
Storage And Handling
Store in a cool, dry environment.
Inactive Ingredient
AUQA,
GLYCERIN,
METHYLPROPANEDIOL,
PHYTOSTEROLS,
BUTYROSPERMUM PARKII (SHEA BUTTER),
NIACINAMIDE,
PHYTOSTERYL GLUCOSIDE,
CETEARYL GLUCOSIDE,
PEG-100 STEARATE,
GLYCERYL STEARATE/ACETATE,
CETEARYL ALCOHOL,
POTASSIUM AZELOYL DIGLYCINATE,
AZELAIC ACID,
MENTHA ARVENSIS LEAF EXTRACT,
CHRYSANTHELLUM INDICUM EXTRACT,
PORTULACA OLERACEA EXTRACT,
SOPHORA ANGUSTIFOLIA ROOT EXTRACT,
ALOE BARBADENSIS LEAF EXTRACT,
PELARGONIUM GRAVEOLENS FLOWER/LEAF/STEM EXTRACT,
CERAMIDE 1,
CERAMIDE 2,
CERAMIDE 3,
CERAMIDE 4,
CERAMIDE 5,
CERAMIDE 6 II,
PIROCTONE OLAMINE,
SALICYLIC ACID,
XYLITOL,
ANHYDROXYLITOL,
CENTELLA ASIATICA LEAF EXTRACT,
TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT,
CHLORELLA VULGARIS EXTRACT,
DURVILLEA ANTARTICA EXTRACT,
CARBOXYMETHYL CHITOSAN,
CARBOMER,
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER,
HYDROXYACETOPHENONE,
1,2-HEXANEDIOL,
QUATERNIUM-73,
o-CYMEN-5-OL,
Otc - Questions
Email at: [email protected]
Package Label.Principal Display Panel
12 (Photo 2026 01 13 16 47 00)
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