Label: SO FRESH SO CLEAN MILD ACNE TREATMENT- salicylic acid cloth

  • 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 25, 2015

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  • PRINCIPAL DISPLAY PANEL

    SO FRESH SO CLEAN MILD ACNE TREATMENT

  • SO FRESH SO CLEAN MILD ACNE TREATMENT 0.5% Salicylic Acid Acne Medication

    35 THICK WIPES

  • Active ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

  • When using this product

    • With other topical acne medications, at the same time or immediately afterwards, increased skin dryness, redness or irritation may occur. If this happens, only one medication should be used unless directed by a doctor.
    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep away from mouth and lips.
  • Stop use and ask doctor if

    skin irritation occurs

  • Keep out of reach of children.

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

  • Directions

    • Cleanse skin thoroughly before applying medication. Remove wipe. Unfold and wipe over entire affected area.
    • Reseal label on package to maintain freshness.
  • Other information

    • Store at room temperature 60-90 F (15-35 C)
  • Inactive ingredients

    Aqua (Water), Glycerin, Propylene Glycol, Dodecyl Polyglucoside, Polysorbate 20, Hexylene Glycol, Benzyl Alcohol, Sodium Lauroamphoacetate, Aloe Barbadensis (Aloe Vera) Leaf Extract, White Tea Extract, Chamomilla Recutita (Chamomile) Extract, Glydant DMDMH, Phenoxyethanol, Peg-40 Hydrogenated Castor Oil, Tocopheryl Acetate (Vitamin E), Disodium EDTA, Fragrance, Iodopropynyl Butycarbamate.

  • QUESTIONS

    For questions or comments or to report serious side effects:

    P.O. Box 230258

    Brooklyn, NY 11223

  • INGREDIENTS AND APPEARANCE
    SO FRESH SO CLEAN MILD ACNE TREATMENT 
    salicylic acid cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69722-733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69722-733-3535 in 1 BAG06/25/2015
    10.00135 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/25/2015
    Labeler - Global Beauty Care, Inc. (068600947)
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