Otc - Active Ingredient
Salicylic Acid 1.0%
Acne Serum
FDA Label NDC 61531-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Packaging Systems, Inc. Dba: Paklab for the product Acne Serum (NDC 61531-101). 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, warnings and precautions, otc - when using, otc - keep out of reach of children, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne medication
Indications & Usage
for treatment of acne
Warnings
For external use only
Warnings And Precautions
Flammable, keep away from open fire or flame
Otc - When Using
When using this product and other topical acne medications at the same time or immediately following use of this product, increased dryness of irritation of skin may occur. If this occurs, only one medication should be used unless directed by a doctor
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Instructions For Use
- Cleanse skin thoroughly before applying medication
- Cover the affected area entirely up to 2 times daily
- If excessinve dryness or peeling occurs, reduce usage to once a day or every other day
- Recommended for daily use
Inactive Ingredient
Water (Aqua), Alcohol Denat., Glycerin, Salix Nigra (Willow) Bark Extract,Vaccinium Myrtillus Fruit Extract,
Pinus Nigra Bud/Needle Extract, Ribes Nigrum (Black Currant) Fruit Extract, Xanthan Gum, Saccharum Officinarum (Sugar Cane) Extract, Salix Alba (Willow) Bark Extract, Spiraea Ulmaria Flower Extract, Levulinic Acid, Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Sodium Levulinate, Citric Acid, Acer Saccharum (Sugar Maple) Extract
Dosage & Administration
Topical gel
* Please review the disclaimer below.
