Otc - Active Ingredient
mineral oil
Isleaf Shine Smooth Lip Glaze Orange
FDA Label NDC 70818-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by C3 Co., Ltd. for the product Isleaf Shine Smooth Lip Glaze Orange (NDC 70818-012). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, 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
Inactive Ingredient
polybutene, lauryl alcohol, etc
Otc - Purpose
skin protectant
Otc - Keep Out Of Reach Of Children
keep out of reach of the children
Indications & Usage
Open the cap, press the button to put suitable amount on the applicator and apply evenly. Keep in a place away from direct sunlight with the cap closed after use
Warnings
1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight
4. Use as avoiding eye areas.
Dosage & Administration
for external use only
Package Label.Principal Display Panel
Label (Label)
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