Label: SULFUR CALMING MASK- sulfur cream

  • NDC Code(s): 70764-103-22, 70764-103-52
  • Packager: CONTROL CORRECTIVE SKINCARE INC
  • 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 September 22, 2023

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  • ACTIVE INGREDIENTS

    SULFUR 10%

  • PURPOSE

    ACNE TREATMENT

  • USE

    A THERAPEUTIC MASK WHICH ABSORBS EXCESS OIL AND CALMS INFLAMMED SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY. DO NOT USE ON BROKEN SKIN. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. DISCONTINUE USE IF IRRITATION BECOMES SEVERE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL ATTENTION OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    Apply a thin layer with fingers to the entire affected areas. Leave on 5 to 10 minutes and then remove with a wet towel or sponge. Also may be used daily to spot treat acneic areas or left directly on blemishes overnight.

  • INACTIVE INGREDIENTS

    WATER, ALOE BARBADENSIS LEAF JUICE, KAOLIN, BENTONITE, GLYCERIN, PROPYLENE GLYCOL, ZINC OXIDE, TITANIUM DIOXIDE, MAGNESIUM ALUMINUM SILICATE, CETYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, TRITICUM VULGARE (WHEAT) GERM OIL, SIMMONDSIA CHINENIS (JOJOBA) SEED OIL, CHAMOMILE RECUTITA (MATRICARIA) FLOWER EXTRACT, EUCALYPTUS GLOBULUS LEAF OIL, PHENOXYETHANOL, METHYLISOTHIAZOLINONE.

  • QUESTIONS OR COMMENTS

    WWW.CONTROLCORRECTIVE.COM

    TOLL FREE 1-866-290-4290   MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    01b UC_Sulfur Calming Mask

  • INGREDIENTS AND APPEARANCE
    SULFUR CALMING MASK 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70764-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    KAOLIN (UNII: 24H4NWX5CO)  
    BENTONITE (UNII: A3N5ZCN45C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70764-103-521 in 1 BOX09/11/2018
    1NDC:70764-103-2257 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/11/2018
    Labeler - CONTROL CORRECTIVE SKINCARE INC (023999357)
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