Label: DUAL EFFECTS MOISTURIZER- salicylic acid lotion

  • NDC Code(s): 62217-158-04
  • Packager: Fruit of the Earth, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 February 10, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredient

    Salicylic Acid 0.25%

  • 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 medicaton at the same time. If irritation occurs, only use one topical acne medicaton at a time.
    • avoid contact with eyes. If contact occurs, flush thoroughly with water
  • Keep out of reach of children

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

  • Directions

    • Cleanse skin throughly before applying this product
    • Cover the entire affected area with a think layer one to three times daily
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily a needed or as directed by doctor.
    • If bothersome dryness or peelin ocur, reduce applicaton 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, Methyl Gluceth-20, Dicetyl Phosphate, Ceteth-10 Phosphate, Mentyl Lacatate, Steareth-21, Steareth-2, Fragrance, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Magnesium Aluminum Silicate, BHT.

  • Label

    Spacology Dual Effects Moisturizer

    4 fl oz (118 mL)

    NDC 62217-158-04

    SP29015EF

  • INGREDIENTS AND APPEARANCE
    DUAL EFFECTS MOISTURIZER 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-158
    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
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-158-04118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/15/2017
    Labeler - Fruit of the Earth, Inc. (079559467)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!