Label: KROGER DUAL EFFECTS MOISTURIZER- 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 October 3, 2022

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  • Active Ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne Medication

  • Uses

    • For the management of acne
  • Warnings

    For external use only

  • When using this product

    • 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.
    • Avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • Keep out of reach of children.

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

  • Directions

    • Cleanse skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer one to three times daily
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Other information

    • may stain some fabrics
  • Inactive Ingredients

    water, dicaprylyl ether, glycerin, cetearyl alcohol, dimethicone, neopentyl glycol diisostearate, neopentyl glycol diethylhexanoate, aluminum starch octenylsuccinate, menthyl gluceth-20, dicetyl phosphate, ceteth-10 phosphate, menthyl lactate, steareth-21, steareth-2, fragrance, xanthan gum, disodium EDTA, sodium hydroxide, magnesium Aluminum Silicate, BHT.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    KROGER DUAL EFFECTS MOISTURIZER 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-870
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    STEARETH-2 (UNII: V56DFE46J5)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-870-04118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F04/26/2018
    Labeler - THE KROGER CO (006999528)
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