Acne Treatment Clear Gel - Maximum Strength
FDA Label NDC 52486-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mccure Health Solutions Inc. for the product Acne Treatment Clear Gel - Maximum Strength (NDC 52486-010). 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, uses, warnings, do not use, when using this product, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Uses

for the treatment and prevention of acne pimples

Warnings

for external use only.

Do Not Use

if you have sensitive skin or are sensitive to Salicylic Acid.

When Using This Product

avoid contact with eyes, lips and mouth.

  • if using with other topical acne medications, at the same time or immediately following use of this product, increased dryness of the skin may occur. If this occurs, only one medication should be used unless otherwise directed by a doctor. Skin irritation may occur characterized by redness, burning, itching, peeling or possible swelling. Mild irriation may be reduced by using this product less frequently or lower concentration. Stop  use and ask a doctor if skin irritation becomes severe.

Keep Out Of Reach Of Children.

If swallowed, ger medical help or contact a Poison Control Center right away.

Directions

Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times day. Use to prevent new pimples from forming.

Other Information

  • store at 15 - 30 C (59 - 86 F)
  • close cap tightly after use
  • do not use if seal on tube is punctured or missing
  • keep away from heat

Inactive Ingredients

DMDM HYDANTOIN, GLYCERIN, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL, WATER

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