Otc - Active Ingredient
Active ingredient
Salicylic acid 2%
Acne Treatment Pads
FDA Label NDC 58194-044
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 Acne Treatment Pads (NDC 58194-044). 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.
Avoid contact with eyes & lip, if contact
occurs, flush throoughly with water.
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 usedunless 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 the skin thoroughly before applying medication
-Use the pad to wipe the entire affected area one to three times daily
-If bothersome dryness or peeling occurs, reduce application to once a day or every other day
-Do not peave pad on skin for an extended period of time.
Storage And Handling
Other information store at room
temperature 68 - 86 F (20 - 30 C)
Inactive Ingredient
Inactive ingredients water, SD
alcohol, glycerin, trideceth - 8,
PEG-12 dimethicone, hamamelis virginiana
flower (witch hazel) water, disodium EDTA,
benzalkonium chloride, sodium hydroxide,
fragrance
Package Label.Principal Display Panel
Image Description (Acne 50)
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