ACNE CLEARING SULFUR MASK- sulfur cream 
AcneFree, LLC

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Acne Clearing Sulfur Mask

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

Other information

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:

LabelTube

ACNE CLEARING SULFUR MASK 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR35 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-001-011 in 1 CARTON12/01/2017
148 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00612/01/2017
Labeler - AcneFree, LLC (122237140)

Revised: 12/2023
Document Id: 0d8084cc-c191-6108-e063-6394a90adf9a
Set id: c0675282-ff00-edba-e053-2995a90ace68
Version: 4
Effective Time: 20231227
 
AcneFree, LLC