Label: LOT- 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 June 6, 2020

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  • Inactive Ingredients

    ammonium carbonate, glycerin, water.

  • Active ingredients

    Citric acid 0.15% Purpose: Antiseptic

    Ascorbic acid 0.21% Purpose: Antiseptic

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

  • Use(s)

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Do not use

    In children less than 2 months of age

    On open skin wounds

  • When using this product

    keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly

    with water.

  • Ask a doctor

    If irritation or rash occurs. This may be a sign of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Other information

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children under 6 years old of age when using this product to avoid swallowing.

  • Purpose

    Purpose: Antiseptic

  • Package label- Principal Display Panel

    1000 mL NDC: 78746-002-01

    Lot

  • INGREDIENTS AND APPEARANCE
    LOT 
    citric acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78746-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 98.75 g  in 100 g
    AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ) 0.1 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78746-002-011000 g in 1 BOTTLE; Type 0: Not a Combination Product06/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/06/2020
    Labeler - Aurelio Muñoz Sagaón (951578972)
    Registrant - Aurelio Muñoz Sagaón (951578972)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurelio Muñoz Sagaón951578972manufacture(78746-002)
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