Label: CARING MILL ACNE DRYING- sulfur 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 June 21, 2021

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  • Drug Facts

  • Active Ingredients

    Sulfur 10%

  • Purpose

    Acne Treatment

  • Use:

    For the treatment of acne. Healing and drying of acne. Penetrates pores to control acne. Helps prevent breakouts.

  • Warnings:

    For external use only.
    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. Stop use and ask a doctor if skin irritation occurs or gets worse. Rinse right away with water if product gets in eyes.

    Keep out of reach of children.

  • Directions:

    DO NOT SHAKE BOTTLE.
    Clean the skin thoroughly before using at night. Apply only to areas with acne. Allow solution to dry and rinse off in the morning.

    Do not use on broken skin or large areas of skin. If bothersome dryness or peeling occurs, reduce application to every other day.

  • Inactive Ingredients:

    Allantoin, Aqua (Deionized Water), Camphor, Ethylhexylglycerin, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminium Silicate, Phenoxyethanol, Salicylic Acid, Zinc Oxide.

  • STORAGE AND HANDLING

    Store at room temperature.

  • SPL UNCLASSIFIED SECTION

    OVERNIGHT TREATMENT FOR STUBBORN ACNE

    Benefits

    • Powerful sulfur and salicylic acid formula penetrates pores and dries out stubborn acne overnight, revealing smaller less noticeable blemishes.

    • Clears acne and promotes healing

    • Emergency spot treatment

    • Reduces size of stubborn acne

    • Fast results

    • Ideal for all skin types

    Powerful overnight acne treatment

    NOT TESTED ON ANIMALS

    Made in the USA

    Manufactured for FSA Store Inc.
    240 W 37th St. 6th Floor
    New York, NY 10018
    Customer Help Line: 
    (844) 425-4948

  • Packaging

    Acne60

  • INGREDIENTS AND APPEARANCE
    CARING MILL ACNE DRYING 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71328-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71328-060-021 in 1 BOX06/21/2021
    1NDC:71328-060-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/21/2021
    Labeler - Clixit, Llc (014971694)
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