Label: HOPE IN A BOTTLE- salicylic acid 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 September 28, 2011

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  • ACTIVE INGREDIENT

    SALICYLIC ACID   2%

  • INACTIVE INGREDIENT

    water

    ethylhexyl palmitate

    cetyl alcohol

    butylene glycol
    glyceryl stearate 
    allyl methacrylates crosspolymer
    ppg-12/smdi copolymer
    dimethicone
    cetearyl alcohol
    tocopheryl acetate
    lavandula angustifolia (lavender) oil
    PEG-100 stearate
    ceteareth-20
    xanthan gum
    polyacrylamide
    c13-14 isoparaffin
    laureth-7
    triethanolamine
    tetrasodium edta
    propylene glycol
    methylparaben
    propylparaben
    diazolidinyl urea

  • ASK DOCTOR

    STOP USE AND ASK A DOCTOR IF EXCESSIVE SKIN IRRITATIONS DEVELOPS OR INCREASES

  • 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

  • PREGNANCY OR BREAST FEEDING

    IF PREGNANT OR BREAST FEEDING ASK A HEALTH PROFESSIONAL BEFORE USE

  • INDICATIONS & USAGE

    HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

    PENETRATES PORES TO CLEAR MOST ACNE BLEMISHES.



    CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING.

    COVER THE ENTIRE EFFECTED AREA 1 TO 3 TIMES DAILY

    BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR STATE WITH 1 APPLICATION DAILY THEN GRADUALLY INCREASE TO 2 OR 3 IF NEEDED OR AS DIRECTED BY YOUR DOCTOR


  • WARNINGS

    FOR EXTERNAL USE ONLY

  • PRINCIPAL DISPLAY PANEL

    MM1

  • PURPOSE

    HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

    PENETRATES PORES TO CLEAR MOST ACNE BLEMISHES.

  • DOSAGE & ADMINISTRATION

    CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING.

    COVER THE ENTIRE EFFECTED AREA 1 TO 3 TIMES DAILY

    BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR STATE WITH 1 APPLICATION DAILY THEN GRADUALLY INCREASE TO 2 OR 3 IF NEEDED OR AS DIRECTED BY YOUR DOCTOR

  • INGREDIENTS AND APPEARANCE
    HOPE IN A BOTTLE 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-2900
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.184 mL  in 59.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-2900-159.2 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/28/2011
    Labeler - Philosophy, Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Philosophy Inc for BioTech Research Labs948102256manufacture
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