Label: CLINICIANS COMPLEX- sulfur lotion

  • NDC Code(s): 61352-001-01
  • Packager: Cosmed Dermaceuticals, 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 January 14, 2022

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  • Active Ingredients:

    Sulfur 10%

  • Purpose

    Acne Treatment

  • Uses:

    For the treatment of acne • Dries up acne pimples • Dries and clears acne blemishes

    Helps keep skin clear of new acne blemishes

  • Warnings:

    For external use only • 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 • Do not use on broken skin or large areas of the skin • When using this product apply only to areas with acne.  Avoid contact with eyes • If excessive irritation develops or increases, discontinue use and consult a doctor • Keep out of reach of children • If swallowed, get medical help or contact Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions:

    ​DO NOT SHAKE SOLUTION​ • Cleanse the skin thoroughly before applying medication • Dip clean cotton swab into sediment and apply directly to blemishes.  Because excessive drying of the skin may occur, limit use to one application daily, or as directed by a physician.

  • Inactive Ingredients:

    Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Magnesium Aluminum Silicate, Salicylic Acid, Iron Oxides.

  • Other Information:

    Protect this product from excessive heat and direct sun light.

  • Questions or Comments:

    Distibuted by: Cosmed Dermaceuticals, Inc.

    Atlanta, GA 30517 • www.cosmedderm.com • Made in USA

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CLINICIANS COMPLEX 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61352-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61352-001-0131.0 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/11/2013
    Labeler - Cosmed Dermaceuticals, Inc. (967008038)
    Registrant - A.I.G. Technologies, Inc. (086365223)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc.086365223manufacture(61352-001) , label(61352-001)
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