Acne Clearing Sulfur Mask Cream
FDA Label NDC 80861-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acnefree, Llc for the product Acne Clearing Sulfur Mask (NDC 80861-001). 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, use, warnings, do not use on, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Sulfur 3.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do Not Use On

  • broken skin
  • large areas of the 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

  • gently massage into clean wet skin for two to three minutes until mask turns light blue
  • leave on for an additional 10 minutes, until dry
  • rinse off with warm water and pat dry
  • if you experience a tightening and cooling effect that you find too strong, rinse off the mask immediately if uncomfortable
  • use 2-3 times per week, or as desired
  • avoid the eye and lip areas

Other Information

  • store at 59°–95° F (15°–35° C)
  • avoid product contact with silver jewelry, which may be discolored by this product

Inactive Ingredients

acacia senegal gum, bentonite, butylene glycol, cellulose, copper gluconate, ethylhexylglycerin, hydroxypropyl methylcellulose, kaolin, magnesium aluminum silicate, magnesium aspartate, magnesium stearate, mannitol, methyl lactate, methylisothiazolinone, phenoxyethanol, sodium ascorbyl phosphate, sodium cocoyl isethionate, spirea ulmaria extract, tetrasodium EDTA, titanium dioxide, ultramarines, water, zinc gluconate, zinc PCA

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