Label: SURFACE CLEANER- citric acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 22, 2021

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  • SPL UNCLASSIFIED SECTION

    1. Citric Acid
    2. Lemon Grass Extract
    3. Water
    4. Quillaja Saponin (Soap Bark)
    5. Stearic Acid

  • Active Ingredient(s)

    Citric Acid

  • Purpose

    Surface Cleaner

  • Use

    For surface cleaning to decrease bacteria.

  • Warnings

    DO NOT CONSUME

  • KEEP OUT OF REACH OF CHILDREN

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

  • Other information

    Store in a cool, dry area, out of reach of children

  • Inactive ingredients

    Lemon Grass Estract, Water, Soap Bark (Quillaja Saponin), Stearic Acid.

  • EPA Excempt Product

    This Product is excempt from the EPA Registration under minimal risk pesticide exception FIFRA Section 25c

  • Directions

    Apply as needed to cover area targeted for antimicrobial cleansing application.

  • Package Label - Principal Display Panel

    Package.Label Principal Display PanelPackage.Label Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SURFACE CLEANER 
    citric acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55549-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID5.6 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    JAMMU LEMONGRASS OIL (UNII: K25ZLU1I0O) 1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW) 0.03 mg  in 100 mL
    STEARIC ACID (UNII: 4ELV7Z65AP) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55549-201-01946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:55549-201-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/30/2020
    Labeler - Southern Chem Industries LLC (056025778)
    Registrant - Southern Chem Industries LLC (056025778)
    Establishment
    NameAddressID/FEIBusiness Operations
    Southern Chem Industries LLC056025778manufacture(55549-201)
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