Gentle Acne Serum Gel
FDA Label NDC 83286-016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Drmtlgy, Llc for the product Gentle Acne Serum (NDC 83286-016). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Medication

Uses

For the treatment of acne.

Warnings

For external use only.

When using this product ​• avoid unnecessary sun exposure and use sunscreen. • avoid contact with eyes, lips and mouth. • avoid contact with hair and dyed products, 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 in a lower concentration

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.

Directions

• Clean the skin thoroughly before applying this product. Apply affected area with a thin layer, avoiding eye area. Allow to absorb before applying additional products. Can be used twice daily or as directed by a physician. If irritation or sensitivity develops, stop use of product and consult a physician.

Inactive Ingredients

Water/Aqua/Eau, Coco-Caprylate/Caprate, Glycerin, Niacinamide, Propanediol, Saccharide Isomerate, Sclerotium Gum, Lysolecithin, Morinda Citrifolia Extract, Xanthan Gum, Pullulan, Potassium Cetyl Phosphate, Panthenol, Allantoin, Trisodium Ethylenediamine Disuccinate, Silica, Phenoxyethanol, Sodium Hydroxide, Ethylhexylglycerin

Packaging

Drmtlgy​ Gentle Acne Serum (83286016 1)

Drmtlgy​ Gentle Acne Serum (83286016 1)

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