Label: ACNE DRYING TOPICAL- sulfur, resorcinol lotion

  • 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 January 23, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Sulfur 8%, Resorcinol 2%

  • DOSAGE & ADMINISTRATION

    Use 1 to 3 times daily on cleansed skin; cover affected area with thin layer; follow with moisturizer

  • INDICATIONS & USAGE

    Treats acne and helps prevent new acne blemishes from forming

  • PURPOSE

    Acne treatment and antiseptic

  • INACTIVE INGREDIENT

    Water, Glycerine, Propylene Glycol, Carbomer 940, Sodium Hydroxide, Potassium Sorbate, Phenoxyethanl, Ethylhexylglycerin

  • WARNINGS

    Warnings: For External Use Only; When using this product keep out of eyes, if contact occurs, flush thoroughly with water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or c.ontact a Poison Control Center.

  • OTHER SAFETY INFORMATION

    If bothersome, dryness or peeling occurs, reduce application to once a day.

  • PRINCIPAL DISPLAY PANEL

    Acne Drying Lotion

  • INGREDIENTS AND APPEARANCE
    ACNE DRYING TOPICAL 
    sulfur, resorcinol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 g  in 100 mL
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70367-012-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/26/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/26/2014
    Labeler - Only Yourx, Inc. (089207519)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!