Suflur Spotandmask Acne Clearing Treatment Mask Cream
FDA Label NDC 35192-200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ca-botana International for the product Suflur Spotandmask Acne Clearing Treatment Mask (NDC 35192-200). 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, otc - active ingredient, otc - purpose, uses, warnings, otc - when using, otc - do not use, sunburn alert, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Otc - Active Ingredient

→ Otc - Purpose

→ Uses

→ Warnings

→ Otc - When Using

→ Otc - Do Not Use

→ Sunburn Alert

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredient

→ Questions Or Comments?

→ Clearstem Sulfur Spot&mask - 1 Fl Oz 30 Ml - Carton

Drug Facts

Otc - Active Ingredient

Active Ingredient

Otc - Purpose

Active Ingredient	Purpose
Sulfur 5%	Ace Treatment

Uses

For the treatment of acne

Warnings

For external use only.

Otc - When Using

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

Otc - Do Not Use

Do not use on

Broken skin
Large areas of the skin

Sunburn Alert

Sunburn Alert: This product contains an Alpha Hydroxy Acid (AHA), increasing sun sensitivity and sunburn risk. Use sunscreen, wear protective clothing, and limit sun exposure during use and for a week after.

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

Apply an even layer onto clean skin
Avoid eye area
leave on for 10 minutes
remove with damp washcloth and warm water
for best results use at least once a week

Inactive Ingredient

Inactive Ingredients

Water, Kaolin, Glycerin, Lactic Acid, Glycolic Acid, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetyl Alcohol, Niacinamide, Sodium Hydroxide, Acacia Senegal Gum, Bentonite, Cetearyl Olivate, Xanthan Gum, Sodium Stearoyl Glutamate, Sorbitan Olivate, Caprylhydroxamic Acid, Hydrolyzed Gardenia Florida Extract, Aloe Barbadensis Leaf Juice, Cannabis Sativa Seed Oil, Lavandula Angustifolia, (Lavender) Oil, Vanilla Planifolia Fruit Extract, Zinc Oxide (CI 77947), Tocophryl Acetate, Glyceryl Caprylate, Triethyl Citrate, Maltodextrin, Sodium PCA, Citric Acid