Label: ULTIMATE DAILY FACE WASH- salicylic acid cream

  • 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 9, 2014

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  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Treatment Indications

    •
    for the treatment of acne
  • Warnings

    For external use only.

    Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

  • Keep Out of Reach of Children.

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

  • Avoid contact with eyes.

    If contact occurs, flush thoroughly with water.

  • Directions

    •
    wet face
    •
    Dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area
    •
    rinse thoroughly with warm water and pat dry
    •
    For best results, use twice a day.
  • Inactive Ingredients

    water, sodium cocoyl isethionate, cetearyl alcohol, stearic acid, sodium hydroxide, glycerin, laureth-3, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance, DMDM hydantoin, caramel, disodium EDTA, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract.

  • Package/Label Principal Display Panel

    America's Choice

    ultimate daily face wash
    acne medication 2% salicylic acid

    dermatological tested

    *Compare to Clearasil Ultra®
    Daily Face Wash ingredients

    FIGHTS ACNE 100%

    6.78 FL OZ (200 mL)

    *This product is not manufactured or distributed by Reckitt Benckiser, owner of the registered trademark Clearasil Ultra®.

    DISTRIBUTED BY ONPOINT INC.:
    2 PARAGON DRIVE
    MONTVALE, NJ 07645
    ©2013. ALL RIGHTS RESERVED.

    Manufactured in Israel 0D34D AD T1

    America's Choice ultimate daily face wash graphic

    Carton Label

  • INGREDIENTS AND APPEARANCE
    ULTIMATE DAILY FACE WASH 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-3 (UNII: F32E4CB0UJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CARAMEL (UNII: T9D99G2B1R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    CISTUS MONSPELIENSIS LEAF (UNII: 1IE70KNO43)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42421-034-111 in 1 CARTON
    1200 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/10/2014
    Labeler - Emilia Personal Care Inc. (965445112)
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