Otc - Active Ingredient
Active Ingredient Purpose
Salicylic Acid 2%--------Acne Treatment
Salicylic Gel
FDA Label NDC 53634-153
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Malin And Goetz Inc for the product Salicylic Gel (NDC 53634-153). 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, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, other safety information, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For external use only
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.
Warnings
Warnings:
For external use only.
When using this product
Avoid contact with eyes. If contact occurs, immediately flush with water.
Dosage & Administration
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 totwo oe three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive Ingredient
Inactive ingredients
Water/Aqua/Eau, Alcohol Denat., Glycerin, Lactic Acid, Hydroxyethylcellulose, Sodium Hydroxide, Centella Asiatica Extract, Niacinamide, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Disodium EDTA, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Artemisia Absinthum Oil, Mentha Viridis (Spearmint) Leaf Oil, Tagetes Minuta Flower Oil, Achillea Millefolium Flower Extract.
Other Safety Information
Other Information
Protect the product in this container from excessive heat and direct sun.
Indications & Usage
Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor.
Package Label.Principal Display Panel
(MALIN+GOETZ)
salicylic gel.
2% Salicylic Acid. Acne Gel
Daytime Treatment
0.5fl.oz./15ml
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