Label: ROYAL ALCOHOL CLEANSING- isopropyl alcohol patch

  • 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 March 10, 2023

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  • Drug Facts

  • Active Ingredient

    Isopropyl Alcohol, 70% v/v

    Purpose

    Antiseptic

  • Use

    for the preparation of skin prior to an injection to decrease germs in minor cuts and scrapes.

  • Warning:

    For external use only

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

    Caution do not apply to irritated skin.

    Do not ues

    in the eyes or on mucous membranes. In case of deep cuts or puncture wounds, consult a doctor.

  • Directions

    wipe injection site vigorously.

  • Other information

    store at room temperature.

  • Inactive ingredient

    water.

  • Package Labeling:

    Label

    Box

  • INGREDIENTS AND APPEARANCE
    ROYAL ALCOHOL CLEANSING 
    isopropyl alcohol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50435-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50435-200-00100 in 1 BOX11/13/2017
    15 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/11/2017
    Labeler - Filo America (943873703)
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