Sulfur Spot Treatment Gel
FDA Label NDC 70707-440

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Face Reality, Inc for the product Sulfur Spot Treatment (NDC 70707-440). 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, 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

Sulfur 6%

Purpose

Acne Treatment

Use

for the treatment of acne

Warnings

For external use only

Do Not Use

  • on broken skin
  • on large areas of skin

When Using This Product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • apply only to areas with acne

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 as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other Information

Store at room temperature. Keep away from heat or direct sunlight.

Inactive Ingredients

Acacia Senegal Gum, Allantoin, Benzyl Alcohol, Bisabolol (L-alpha), Butylene Glycol, Caprylhydroxamic Acid, Carbomer, Dextran, Ethylhexylglycerin, Glycerin, Palmitoyl Tripeptide-8, Phenoxyethanol, Sodium Hydroxide, Water.

Questions Or Comments?

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