DRX BLEMISH CLARIFYING MASK- sulfur lotion

DRx Blemish Clarifying Mask by

Drug Labeling and Warnings

DRx Blemish Clarifying Mask by is a Otc medication manufactured, distributed, or labeled by Dr. Dennis Gross Skincare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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

Purpose

Acne Treatment

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

Warnings

For external use only

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

Do not use on:

• broken skin
• large areas of the skin

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

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

Questions?

Call 1-888-830-7546

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

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 ℮

INGREDIENTS AND APPEARANCE

DRX BLEMISH CLARIFYING MASK 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58633-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Kaolin (UNII: 24H4NWX5CO)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Butylene Glycol (UNII: 3XUS85K0RA)
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 60 (UNII: CAL22UVI4M)
Acacia (UNII: 5C5403N26O)
Zinc Oxide (UNII: SOI2LOH54Z)
Bentonite (UNII: A3N5ZCN45C)
Safflower Oil (UNII: 65UEH262IS)
Phenoxyethanol (UNII: HIE492ZZ3T)
Levomenol (UNII: 24WE03BX2T)
Allantoin (UNII: 344S277G0Z)
Rosemary Oil (UNII: 8LGU7VM393)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Phenylethyl Resorcinol (UNII: G37UFG162O)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Ethylhexylglycerin (UNII: 147D247K3P)
Soybean Oil (UNII: 241ATL177A)
Opuntia Ficus-Indica Whole (UNII: 23Z87HTQ6P)
Farnesol (UNII: EB41QIU6JL)
Glycyrrhiza Glabra (UNII: 2788Z9758H)
Salix Alba Bark (UNII: 205MXS71H7)
Retinol (UNII: G2SH0XKK91)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58633-704-10	1 in 1 BOX	03/01/2020
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	03/01/2020

Labeler - Dr. Dennis Gross Skincare (008190808)