Label: BLEMISH SPOT TREATMENT- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 28, 2024

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

  • Active Ingredients

    Active Ingredients

    Salicylic Acid 1%

  • Purpose

    Purpose

    Acne Treatment

  • Uses

    Uses

    • For the treatment of acne.
    • Dries and clears acne blemishes and allows skin to heal.
    • Penetrates pores to reduce the number of acne blemishes, blackheads, and whiteheads.
    • Helps prevent the development of new acne blemishes, blackheads, and whiteheads.
  • Questions or comments?

    Questions or comments?

    Skin Script™

    Chandler, AZ 85226

    www.skinscriptrx.com

  • Warnings

    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.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison

    Control Center right away.

  • Keep Out of Reach of Children

    Keep out of reach of children.

  • Directions

    Directions

    · Clean the 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 a skin care professional · If bothersome dryness or

    peeling occurs, reduce application to once a day or every other day

  • Inactive Ingredients

    Inactive Ingredients

    Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Glycolic Acid, Coco-Caprylate/Caprate,

    Cetearyl Alcohol, Cetearyl Glucoside, Glyceryl Stearate, Dicaprylyl Ether, Gluconolactone,

    Xanthan Gum, Sodium Benzoate, Lithium Magnesium Sodium Silicate, Acetyl Tributyl Citrate,

    Hamamelis Virginiana (Witch Hazel) Water, Fructooligosaccharides (D-beta), Alcohol,

    Glucosamine HCl (D), Phenyl t-Butylnitrone (Spin Trap), Citric Acid, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    BLEMISH SPOT TREATMENT 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83657-472
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    LAPONITE (UNII: D703131383)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENYL-N-TERT-BUTYLNITRONE (UNII: 3I91332OPG)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83657-472-0115 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00610/01/2024
    Labeler - Skin Script, LLC (050951910)