ACNE CLEARING SULFUR MASK- sulfur cream

Acne Clearing Sulfur Mask by

Drug Labeling and Warnings

Acne Clearing Sulfur Mask by is a Otc medication manufactured, distributed, or labeled by AcneFree, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Questions or comments?

1-888-768-2913

Package Labeling:

INGREDIENTS AND APPEARANCE

ACNE CLEARING SULFUR MASK 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80861-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
COPPER GLUCONATE (UNII: RV823G6G67)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
METHYL LACTATE, (-)- (UNII: 0379G9C44S)
ACACIA (UNII: 5C5403N26O)
BENTONITE (UNII: A3N5ZCN45C)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
EDETATE SODIUM (UNII: MP1J8420LU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ULTRAMARINE BLUE (UNII: I39WR998BI)
WATER (UNII: 059QF0KO0R)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
ZINC PIDOLATE (UNII: C32PQ86DH4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-001-01	1 in 1 CARTON	12/01/2017
1		48 g 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	12/01/2017

Labeler - AcneFree, LLC (122237140)