Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 7093a8d4-1910-4b23-9d88-d3398db0916a
Route
TOPICAL
Published
Effective Date 2024-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (50 mg)
Inactive Ingredients
Water Kaolin Cetostearyl Alcohol Butylene Glycol Glycerin Polysorbate 60 Acacia Zinc Oxide Bentonite Safflower Oil Phenoxyethanol Levomenol Allantoin Rosemary Oil Aloe Vera Leaf Phenylethyl Resorcinol Sodium Pyrrolidone Carboxylate .alpha.-tocopherol Acetate Ethylhexylglycerin Soybean Oil Opuntia Ficus-indica Whole Farnesol Glycyrrhiza Glabra Salix Alba Bark Retinol Citric Acid Monohydrate Potassium Sorbate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01

Description

Sulfur 5.0% ...........................................

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Sulfur 5.0% ...........................................

Uses
  • for the treatment and management of acne
  • penetrates pores to eliminate most acne blemishes and blackheads
  • helps prevent development of new acne blemishes and blackheads
Section 50565-1

Keep out of the reach of children.If swallowed, get medical help or contact a Poison Center right away.

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily. Leave on for at least 10 minutes, then rinse.
  • for use as a deeper treatment, apply a thick layer to targeted area as a spot treatment or as an overnight mask. Wash off in the morning.
  • suitable for use on face, chest, and back
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • 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
Questions?

Call 1-888-830-7546

Monday through Friday, 9:00 AM to 5:00 PM EST

Do Not Use On:
  • broken skin
  • large areas of the skin
Active Ingredient

Sulfur 5.0% ...........................................

Inactive Ingredients:

Water/Aqua/Eau, Kaolin, Cetearyl Alcohol, Glycerin, Butylene Glycol, Polysorbate 20, Acacia Senegal Gum, Zinc Oxide, Bentonite, Carthamus Tinctorius (Safflower) Seed Oil, Farnesol, Opuntia Vulgaris Extract, Salix Alba (Willow) Bark Extract, Bisabolol, Retinol, Phenylethyl Resorcinol, Glycyrrhiza Glabra (Licorice) Root Extract, Tocopherol, Aloe Barbadensis LeafJuice, Tocopheryl Acetate, Glycine Soja (Soybean) Oil, Sodium PCA, Allantoin, Ethylhexylglycerin, Rosmarinus Officinalis (Rosemary) Leaf Oil, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate

When Using This Product:
  • avoid contact with eyes
  • 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
Principal Display Panel – 30 Ml Box Label

Dr Dennis Gross

DRx Blemish Solutions™

Clarifying Mask

with Colloidal Sulfur

Acne Medication

You have:Oily skin, acne, breakouts,

enlarged pores, and

blackheads

You want:Balanced, blemish-free,

clear, and soothed skin

Net Wt 1.0 oz/30g ℮


Structured Label Content

Uses
  • for the treatment and management of acne
  • penetrates pores to eliminate most acne blemishes and blackheads
  • helps prevent development of new acne blemishes and blackheads
Section 50565-1 (50565-1)

Keep out of the reach of children.If swallowed, get medical help or contact a Poison Center right away.

Purpose

Acne Treatment

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily. Leave on for at least 10 minutes, then rinse.
  • for use as a deeper treatment, apply a thick layer to targeted area as a spot treatment or as an overnight mask. Wash off in the morning.
  • suitable for use on face, chest, and back
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • 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
Questions?

Call 1-888-830-7546

Monday through Friday, 9:00 AM to 5:00 PM EST

Do Not Use On: (Do not use on:)
  • broken skin
  • large areas of the skin
Active Ingredient

Sulfur 5.0% ...........................................

Inactive Ingredients:

Water/Aqua/Eau, Kaolin, Cetearyl Alcohol, Glycerin, Butylene Glycol, Polysorbate 20, Acacia Senegal Gum, Zinc Oxide, Bentonite, Carthamus Tinctorius (Safflower) Seed Oil, Farnesol, Opuntia Vulgaris Extract, Salix Alba (Willow) Bark Extract, Bisabolol, Retinol, Phenylethyl Resorcinol, Glycyrrhiza Glabra (Licorice) Root Extract, Tocopherol, Aloe Barbadensis LeafJuice, Tocopheryl Acetate, Glycine Soja (Soybean) Oil, Sodium PCA, Allantoin, Ethylhexylglycerin, Rosmarinus Officinalis (Rosemary) Leaf Oil, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate

When Using This Product: (When using this product:)
  • avoid contact with eyes
  • 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
Principal Display Panel – 30 Ml Box Label (Principal Display Panel – 30 mL Box Label)

Dr Dennis Gross

DRx Blemish Solutions™

Clarifying Mask

with Colloidal Sulfur

Acne Medication

You have:Oily skin, acne, breakouts,

enlarged pores, and

blackheads

You want:Balanced, blemish-free,

clear, and soothed skin

Net Wt 1.0 oz/30g ℮


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)