Label: ACNEFREE THERAPEUTIC SULFUR MASK- sulfur cream

  • NDC Code(s): 0187-1619-02
  • Packager: Valeant Pharmaceuticals North America LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 30, 2015

If you are a consumer or patient please visit this version.

  • Active ingredient

    Sulfur 3.5%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

  • When using this product

    Skin irritation and dryness are 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 get into eyes.
  • Do Not Use on:

    broken skin
    large areas of the body
  • Stop use and consult a doctor

    if skin irritation occurs or gets worse.

  • 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 for maximum absorption. Leave on for an additional 10 minutes, until dry. Rinse off with warm water and pat dry. You may experience a tightening and cooling effect. Some individuals may find the cooling feeling too strong - simply 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, menthyl lactate, methylisothiazolinone, phenoxyethanol, sodium ascorbyl phosphate, sodium cocoyl isethionate, spiraea ulmaria extract, tetrasodium EDTA, titanium dioxide, ultramarines, water, zinc gluconate, zinc PCA

  • Questions or Comments?

    1-800-321-4576

    Distributed by: Valeant Consumer Products,

    a division of Valeant Pharmaceuticals North America LLC,

    Bridgewater, NJ 08807

    acnefree.com

    Made in USA

    ©2015

    Rev. 01/15

    9381401

  • Package/Label Principal Display Panel

    AcneFree®

    CLEAR SKIN TREATMENTS

    Therapeutic

    Sulfur Mask

    with Vitamin C & Copper

    Helps to:

    Clear Acne
    Absorb Excess Oil
    Unclog Pores

    COLOR-SIGNAL

    TECHNOLOGY

    Changes color to signal

    maximum absorption

    NET WT 1.7 OZ (48 g)

    AcneFree Therapeutic Sulfur Mask - 1.7 oz Carton
  • INGREDIENTS AND APPEARANCE
    ACNEFREE THERAPEUTIC SULFUR MASK 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-1619
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR35 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    BENTONITE (UNII: A3N5ZCN45C)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0187-1619-021 in 1 CARTON
    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 finalpart333D09/09/2014
    Labeler - Valeant Pharmaceuticals North America LLC (042230623)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei LLC105803274MANUFACTURE(0187-1619)