Label: ZITLOX SALICYLIC ACNE- salicylic acid gel

  • NDC Code(s): 69546-201-02
  • Packager: ASA Universal Inc. dba: SONAGE
  • 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 April 15, 2022

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  • Active Ingredient

    Salicylic Acid 1.5%

  • Purpose

    Acne Treatment

  • Uses

    •
    clears acne blemishes and allows skin to heal
    •
    helps prevent new acne blemishes from forming
  • 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

    •
    clean the skin thoroughly before applying this product.
    •
    cover the entire affected area with a thin layer one to three time 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 doctor
    •
    if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Inactive Ingredients

    bacillus ferment filtrate extract (postbiotic), benzyl alcohol, carthamnus tinctorius (safflower) oil, cocos nucifera (coconut) oil, dehydroacetic acid, diatomaceous earth, eucalyptus globulus leaf oil, glycerin, helianthus annuus (sunflower) seed oil, melaleuca alternifolia (tea tree) leaf oil, melia azadirachta (neem) seed oil, mentha piperita (peppermint) oil, olea europaea (olive) fruit oil, polyacrylate crosspolymer-6, sodium hydroxide, t-butyl alcohol, water, xanthan gum

  • Principal Display Panel

    SONÄGE®

    ZITLOX
    SALICYLIC
    ACNE GEL
     
    CLEARS ACNE
    BLEMISHES

    Dermatologist Tested
    Clinically Tested
     

    POSTBIOTIC
    TEA TREE
    EUCALYPTUS

    15 ml. / 0.5 fl. oz.
    THE NEW NATURAL®

     

    Dist. by/par Sonäge, Santa Monica,
    CA 90405 U.S.A
    sonage.com

    image-01

    Label

  • INGREDIENTS AND APPEARANCE
    ZITLOX SALICYLIC ACNE 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69546-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69546-201-021 in 1 CARTON06/30/2022
    115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/30/2022
    Labeler - ASA Universal Inc. dba: SONAGE (054687895)
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