Label: LIGHTS ISOPROPYL ALCOHOL PREP PADS- isopropyl alcohol solution

  • NDC Code(s): 61333-206-01
  • Packager: Lights Medical Manufacture Co., Ltd.
  • 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 January 16, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient: Isopropyl Alcohol 70%

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Uses for preparation of the skin prior to injection

  • DOSAGE & ADMINISTRATION

    Directions:

    Apply to skin as needed

    Do not get into eyes

    Discard after single use

    Do not apply over large area of the body

    If irritation and redness develop, discontinue use and consult a healthcare professional

    If accidentally swallowed, seek medical assistance or contact a Poison Control Center right away

  • WARNINGS

    Warnings:

    For external use only

    Flammable. Keek away from fire or flame.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 

  • OTHER SAFETY INFORMATION

    Other information

    • Do not flush
    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive Ingredient

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LIGHTS ISOPROPYL ALCOHOL PREP PADS 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61333-206-013.5 mL in 1 PATCH; Type 0: Not a Combination Product08/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2019
    Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
    Registrant - Lights Medical Manufacture Co., Ltd. (529128649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-206)
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