Otc - Active Ingredient
Active ingredient
Salicylic acid 2%
Advanced Acne Spot Treatment
FDA Label NDC 58194-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Weierya Daily Chemicals Factory for the product Advanced Acne Spot Treatment (NDC 58194-030). 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 - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Acne treatment
Indications & Usage
Uses for the treatment of acne
Warnings
Warnings
For external use only.
Flammable. Keep away from fire or flame.
Ask a doctor or pharmacist before using other topical
acne medications at the same time or immediately
following use of this product. May increase dryness or
irritation of the skin. If this occurs, only one medication
should be used unless directed by a doctor.
When using this product apply to affected area only.
Do not use on broken skin or apply to large areas of the
body.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center right
away.
Dosage & Administration
Directions
-Cleanse skin thoroughly before applying.
-Cover the entire affected area with a thin layer one to
three times daily. Because excessive drying of the skin
may occur, start with one application daily, then
gradually increase to two or three times daily if needed
or directed by a doctor. If bothersome dryness or
peeling occurs, reduce application to once a day or
every other day.
Storage And Handling
Other information store at room
temperature 68 - 86 F (20 - 30 C)
Inactive Ingredient
Inactive ingredients alcohol, ammonia,
benzalkonium chloride, butylene glycol, dimethicone,
disodium EDTA, glycerin, hamamelis virginiana extract,
laureth-7, menthyl lactate, paraffin, phenoxyethanol,
polyacrylamide, portaluca oleracea extract, propylene
glycol, water, xanthan gum
Package Label.Principal Display Panel
Copy Of Label (Acne Label)
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