Label: CVS HEALTH ADVANCED ACNE SPOT TREATMENT- salicylic acid gel

  • NDC Code(s): 69842-464-51, 69842-464-52
  • Packager: CVS PHARMACY
  • 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 May 16, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient

    Salicylic acid 2.0%

  • Purpose

    Acne Medication

  • Uses

    • For the treatment of acne
  • Warnings

    For external use only

    FLAMMABLE: Keep away from spark, heat, or flame.

  • 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, fluch thoroughly with water.
  • 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

    • Cleanse skin thoroughly before applying product.
    • Cover the entire afffected 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 a 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, alcohol denat, hamamelis virginiana (witch hazel) extract, polyacrylamide, C13-14 isoparaffin, glycerin, cyclopentasiloxane, C12-15 alkyl lactate, laureth-7, phenoxyethanol, cetyl lactate, PPG-2 isoceteth-20 acetate, cocamidopropyl PG-dimonium chloride phosphate, polysorbate 20, phenethyl dimethicone, fragrance, dehydroxanthan gum, hexylene glycol, ammonium hydroxide, tetrasodium EDTA, butylene glycol, capryloyl glycine, sarcosine, cinnamomum zeylanicum bark extract, cedrus atlantica bark extract, portulaca oleracea extract

  • PRINCIPAL DISPLAY PANEL

    CVS25801A

    CVS25801K

    CVS31698A

    CVS31698K

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH ADVANCED ACNE SPOT TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-464
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALCOHOL (UNII: 3K9958V90M)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    PURSLANE (UNII: M6S840WXG5)  
    PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    AMMONIA (UNII: 5138Q19F1X)  
    CETYL LACTATE (UNII: A7EVH2RK4O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SARCOSINE (UNII: Z711V88R5F)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-464-521 in 1 CARTON05/14/2019
    1NDC:69842-464-5122.1 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/14/2019
    Labeler - CVS PHARMACY (062312574)