Label: SULFUR- sulfur soap soap

  • 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 April 2, 2022

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  • Active Ingredient

    Sulfur10.0% ，Salicylic Acid3.0%

  • Purpose

    Acne Treatment

  • Warnings

    For external use only

  • Do not use

    On broken skin on large areas of the skin

  • When Using This Product

    Apply only to areas with acne.

    Do not allow contact with the eyes and mucous membranes.

    If undue skin irritation develops or increases , discontinue use and consult a physician.

    Skin irritation and dryness are more likely to occur if you use another topical medication at the same time.

    If irritation occurs , only use one topical acne medication at a time.

  • STOP USE

    If undue skin irritation develops or increases , discontinue use and consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children.

    If swallowed , get medical help or contact a Poison Control Center right away.

  • Directions

    Make lather with sponge.

    Apply to affected areas.

    Leave lather on skin for 3 to 5 minutes.

    Rinse thoroughly with water and gently pat dry with a clean toweI.

    May be used 1 to 3 times a day or as directed by a doctor

  • Other information

  • Inactive ingredients

    Sodium palmitate, Sodium palm kernelate, Water , Glycerin , Tetrasodium EDTA ,Soyethyl morpholinium ethosulfate , Lavender essential oil

  • Indications

    For use in the management of acne.

    Dries up blackheads and whiteheads.

    Penetrates pores to eliminate most acne pimples.

    Helps keep skin clear of new acne blemishes

  • Package Label - Principal Display Panel

    120g 78565-106-01

    78565-106-01

  • INGREDIENTS AND APPEARANCE
    SULFUR 
    sulfur soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78565-106
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78565-106-02240 g in 1 BOX; Type 0: Not a Combination Product12/25/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/25/2021
    Labeler - Meixin Beauty & Health Care Products Co., Ltd. (421458605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Meixin Beauty & Health Care Products Co., Ltd.421458605manufacture(78565-106)
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