Active Ingredient
Salicylic acid 1%
Sylvirene Milia Remover Liquid
FDA Label NDC 85248-071
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Sylvirene Milia Remover (NDC 85248-071). 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
Milia Remover
Use
For the removal of milia (skinbumps) Aids in exfoliating dead skin cells Helps smooth skin texture
Warnings
For external use only
Do Not Use
If severe irritation develops,discontinue use.
When Using
Avoid contact with eyes, lips, and mucous membranes. If contact occurs,rinse thoroughly with water.Do not apply to broken, irritated,or sunburned skin.Excessive drying or peeling mayoccur.
Stop Use
Condition worsens or does not improve within 4 weeks.Severe redness, burning, or swelling occurs.
Ask Doctor
Condition worsens or does not improve within 4 weeks.Severe redness, burning, or swelling occurs.
Keep Oot Of Reach Of Children
Keep out of reach of children.
Directions
1.Cleanse and dry the affected skin area thoroughly. 2.Apply a thin layer of the product directly onto the milia (skin bumps) once or twice daily, as needed. 3.Gently massage until fully absorbed. 4.For best results, use consistently for 4 weeks.
Other Information
If pregnant or breast-feeding, ask ahealth professional before use.
Inactive Ingredients
Glycerin.dextrin.xanthan.gum.amylopectin. tocopheryl acetate.water.
Principal Display Panel
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