Label: AMAZON BASICS ADVANCED BLEMISH SPOT TREATMENT ACNE MEDICATION- salicylic acid lotion

  • NDC Code(s): 72288-386-01
  • Packager: AMAZON.COM SERVICES LLC
  • 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 September 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Acne medication

  • Use

    ⬥
    for the treatment 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 medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    ⬥
    avoid contact with the eyes. If contact occurs, flus thoroughly with water.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • 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 doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Other Information

    store at room temperature.

    ⬥
    Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
  • Inactive ingredients

    carbomer, ceramide AP, ceramide EOP, ceramide NP, cholesterol, disodium EDTA, ethylhexylglycerin, glycerin, glycolic acid, hydroxypropyl guar, lactic acid, niacinamide, phenoxyethanol, phytosphingosine, sodium benzoate, sodium hyaluronate, sodium hydroxide, sodium lauroyl lactylate, sodium polyacrylate, water, xanthan gum.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Amazon.com Services LLC
    Seattle, WA 98109

  • PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton

    amazon basics

    advanced
    blemish
    spot
    treatment

    Salicylic Acid
    Acne Medication

    0.75 FL OZ (22 mL)

    PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    AMAZON BASICS ADVANCED BLEMISH SPOT TREATMENT   ACNE MEDICATION
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-386
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Ceramide AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    Ceramide NP (UNII: 4370DF050B)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    Niacinamide (UNII: 25X51I8RD4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Phytosphingosine (UNII: GIN46U9Q2Q)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-386-011 in 1 CARTON08/28/2023
    122 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D08/28/2023
    Labeler - AMAZON.COM SERVICES LLC (128990418)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC255106239MANUFACTURE(72288-386) , LABEL(72288-386) , PACK(72288-386)
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