Active Ingredient
Salicylic Acid 2%
Spot Acne Treatment Oil Free 0.75oz Cream
FDA Label NDC 58503-204
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by China Ningbo Shangge Cosmetics Technology Corp. for the product Spot Acne Treatment Oil Free 0.75oz (NDC 58503-204). 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 if you, when using this product, stop use and ask a doctor if, 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
Purpose
Acne Medication
Use
For the treatment of acne
Warnings
When using this product
skin irritation and dryness is more likely to occur if you use another topical cene medication at the same time. If irritation occurs, only use one topical
acne medication at a time.
Do Not Use If You
Do not use if you have very sentitive skin.
When Using This Product
avoid unnessary sun exposure and use sunscreen.
avoid contact with eyes, lips, and mouth.
avoid contact with hair and dyed fabrics, which may be bleached by this product.
skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less
frequently or a lower concentration.
Stop Use And Ask A Doctor If
irritation becomes severer.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Clean the skin thoroughly before applying this product.
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 some drynesss or peeling occurs, reduce application to once a day or every other day.
If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Other Information
Store at 20°C-25°C (68°F-77°F)
Inactive Gredients
Water
Alcohol
Phenyl Trimethicone
C13-14 Isoparaffin
Laureth-7
Polyacrylamide
Glycerin
Hamamelis Virginiana (Witch Hazel) Exact
Polysorbate 20
Phenoxyethanol
Propylene Glycol
Xanthan Gum
Fragrance
Cyclopentasiloxane
C12-15 Alkyl Lactate
Cetyl Lactate,
PPG-2 Isoceteth-20 Acetate
Myristamidopropyl PG-dimonium Chloride Phosphate
Benzalkonium Chloride,
Disodium EDTA,
Butylene Glycol,
Capryloyl Glycine,
Sarcosine
Cinnamomum Zeylanicum Bark Extract,
Cedrus Atantica Bark Extract,
Portulaca Oleracea Extact
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