Sulfur Spot Treatment Cream
FDA Label NDC 85439-0102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Banuskin, Inc. for the product Sulfur Spot Treatment (NDC 85439-0102). 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 ingredients, purpose, uses, warnings, when using this product, do not use on, 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 Ingredients

→ Purpose

→ Uses

→ Warnings

→ When Using This Product

→ Do Not Use On

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

→ Dosage & Administration

→ Label

Active Ingredients

Sulfur 10%

Purpose

Acne treatment

Uses

For the treatment of acne

Warnings

For external use only

When Using This Product

When using this product

skin irritation and dryness 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.

When using this product

apply only to areas with acne

Do Not Use On

Do not use on

broken skin
large areas of the skin

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.
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.

Inactive Ingredients

Aqua/Water/Eau, Glycerin, Kaolin, Bentonite, Propylene Glycol, Niacinamide, Sorbitol, Titanium Dioxide (Cl 77891), Phenoxyethanol, Hamamelis Virginiana (Witch Hazel) Water, Acacia Senegal Gum, Xanthan Gum, Alpha-Glucan Oligosaccharide, Carbomer, Poiyglyceryl-4 Caprate, Polyglyceryl-6 Caprylate, Chromium Oxide Green (Cl 77288), Butylene Glycol, Potassium Sorbate, Sodium Benzoate, Glycyrrhiza Glabra (Licorice) Root Extract, Salix Nigra (Willow) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Benzoic Acid.