Label: ISOPROPYL ALCOHOL- 200 wet wipes cloth

  • 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 21, 2023

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  • Active ingredients

    ISOPROPYL ALCOHOL - 75% v/v ..............................................(Antiseptic)

  • USE

    Hand sanitizer to decrease bacteria on the skin.

    Recommended for repeated use.

  • INDICATIONS & USAGE

    Clean hands to avoid bacterial infection

  • Warning

    For extenal use only.

    Flammable. Keep away from fire or flame.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children.

  • Do not use

    Do not use in or near the eyes. lf contact occurs, rinse thoroughly with water.

  • Stop use and ask a doctor if

    Rash or irritation develops and lasts more than 24 hrs.
    lf swallowed , get medical help or contact a Poison ControlCenter immediately.

  • DOSAGE & ADMINISTRATION

    Rub hands thoroughly with product.
    Rub hands together until dry.
    Children under 6 years of age should be supervised whenusing this product.

  • Inactive ingredients

    ALOE VERA LEAF, CHAMOMILE, PROPYLENE GLYCOL, TOCOPHEROL, WATER

  • Other Information

    Store at room temperature 68°F to 77°F(20° to 25°C).
    Do not expose to heat or open flame. May discolor certain fabrics.

  • Package Label

    DF

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    200 wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83290-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL2.97 g
    Inactive Ingredients
    Ingredient NameStrength
    CHAMOMILE (UNII: FGL3685T2X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83290-001-01200 in 1 BAG; Type 0: Not a Combination Product02/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/22/2023
    Labeler - Amtime, Inc. (191606748)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amtime, Inc.191606748label(83290-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGSU MEIFAN BIOTECHNOLOGY CO., LTD.554530918manufacture(83290-001)
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