Label: ASTRINGENT- salicylic acid liquid

  • 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 3, 2019

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

  • Active ingredinet

    Salicylic acid 0.5%

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  • Purpose

    Acne medication

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  • Use

    for the treatment of acne

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  • Warnings

    For external use only

    Flammable. Keep away from fire or flame

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  • 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 irrition occurs, only use one topical acne medication at a time
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  • Keep out of reach of children.

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

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  • Directions

    • clean the skin thoroughly before applying this product
    • cover the entire affected are with a thin layer and rinse thoroughly one to three times daily
    • because excessive drying of the sking may occur, start with one application daily, then grdually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
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  • inactvie ingredients

    alcohol (24.5%), algae extract, aloe barbadensis leaf extract, benzophenone-4, denatonium benzoate, dimethicone propyl PG-getaine, fragance, glycerin, isoceteth-20, PEG-32, propylene glycol, sodium citrate, water, blue 1

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  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Sensitive Skin Deep Cleaning Astringent.

    Manufactured for Big Lots by: Vi-Jon, Inc.

    8515 Page Avenue; St. Louis, MO 63114

    Made in the USA with US and Foreign Components

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  • Principal display panel

    SOUND BODY

    COMPARE TO CLEAN & CLEAR DEEP CLEANING ASTRINGENT*

    Sensitive Skin Astringent

    SALICYLIC ACID ACNE MEDICATION

    • Deep cleaning astringent
    • Gentle formula that helps treat and prevents pimples

    8 FL OZ (237 mL)

    image description

    875.002/875AE

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  • INGREDIENTS AND APPEARANCE
    ASTRINGENT 
    salicylic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-875
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    PEG-32 DIOLEATE (UNII: TOM07RFH74)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    water (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50594-875-34 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 03/15/2016
    Labeler - Big Lots (017885351)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(50594-875)
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