Label: STOP SPOT- salicylic acid gel

  • 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 January 13, 2023

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  • Drug Facts

  • Active ingredient 

    Salicylic Acid 2%

  • Purpose

    Acne treatment

  • Uses

    Clears acne blemishes and allows the skin to heal

  • 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 ingested, seek medical help or contact Poison
    Control Center immediately

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Clean the skin thoroughly before applying this product
    • cover the entire affected area/spot 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

    Store below 30°C (86° F)

  • Inactive ingredients

    water, alcohol denat, glycerin, butylene glycol, propanediol, PEG-30 castor oil, dipotassium glycyrrhizate, phenoxyethanol, glycolic acid, sclerotium gum,xanthum gum, sodium hydroxide, farnesol, ethylhexylglycerin, sulfur

  • Product label

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  • INGREDIENTS AND APPEARANCE
    STOP SPOT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72521-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PEG-30 CASTOR OIL (UNII: GF873K38RZ)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FARNESOL (UNII: EB41QIU6JL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SULFUR (UNII: 70FD1KFU70)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72521-001-011 in 1 CARTON07/01/2021
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2021
    Labeler - Clearly Pte Ltd (659280734)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHAKS COSMETIC DESIGN & SERVICES PTE LTD595557596manufacture(72521-001)
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