Label: SULFUR ACNE TREATMENT- sulfur soap

  • NDC Code(s): 74553-013-01
  • Packager: Xtreme Tools International, 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 11, 2023

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

View All Sections
  • Drug Facts

  • Active Ingredient

    Sulfur (10%)

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne.

  • Warning

    For External use only

  • When using this product

    ■ apply only to areas with acne. ■ 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 medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • Do not use on

    ■ broken skin ■ Large areas of the skin.

  • 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

    Wet face. Work soap into a lather with hands and gently massage onto skin. Rinse.

  • Inactive Ingredients

    Sodium Palmate, Sodium Palm Kernelate, Sodium Cocoate, Water (Aqua), Glycerin, Cocos nucifera (Coconut) Oil, Rosa Moschata Seed (Rosehip) Oil, Psidium Guajava Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Allantoin, Tocopheryl Acetate, Tetrasodium Etidronate, Sodium Chloride, Fragrance.

  • QUESTIONS

    Questions or comments?
    Call 1-305-622-7474 Mon-Fri 9 am-5 pm

  • Pacakge Label

    NDC 74553-13-01

    Facial Soap

  • INGREDIENTS AND APPEARANCE
    SULFUR ACNE TREATMENT 
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-013
    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
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)  
    PSIDIUM GUAJAVA LEAF (UNII: PM0F263X0Y)  
    PAPAYA (UNII: KU94FIY6JB)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74553-013-01155 g in 1 BOX; Type 0: Not a Combination Product09/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00609/12/2023
    Labeler - Xtreme Tools International, Inc (125398904)
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!