Label: ACNE CALMING WATER CREAM- salicylic acid cream

  • NDC Code(s): 76354-416-01, 76354-416-02
  • Packager: e.l.f. Cosmetics, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 24, 2024

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  • Drug Facts

  • Active ingredients

    Salicylic Acid 1%

    Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Helps prevent new acne blemishes
  • 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.

    Keep out of reach of children.

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

  • Directions

    Cleanse the skin thoroughly before applying medication. 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 a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated eleswhere on this label.

  • Inactive ingredients

    Water (Aqua), Niacinamide, Glycerin, Silica, Propanediol, Isododecane, Tranexamic Acid, Glyceryl Stearate Citrate, C12-15 Alkyl Benzoate, Acetyl Glucosamine, Tromethamine, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Cetearyl Alcohol, Capryloyl Glycine, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflowe) Seed Oil, Disodium EDTA, Caprylic Acid, Sodium Citrate May Contain: Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77492)

  • Questions or comments

    1-888-315-9814

  • Package Labeling:50ml

    4016-01-01416-01

  • Package Labeling:30ml

    416-02

    5-416-02

  • INGREDIENTS AND APPEARANCE
    ACNE CALMING WATER CREAM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ISODODECANE (UNII: A8289P68Y2)  
    TRANEXAMIC ACID (UNII: 6T84R30KC1)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-416-011 in 1 CARTON02/25/2022
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:76354-416-021 in 1 CARTON02/25/2022
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/25/2022
    Labeler - e.l.f. Cosmetics, Inc. (093902816)
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