Label: 70% ISOPROPYL ALCOHOL PREP PAD- isopropyl alcohol 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 December 30, 2020

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  • Active Ingredient(s)

    ACTIVE INGREDIENT: Isopropyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    USES: Sterile antiseptic wipe, recommended for single use.

  • Warnings

    FLAMMABLE. Keep away from fire, electrical & spark
    For external use only. Do not use In ears, eyes or mouth.
    ●Avoid contact with the eyes. In case of contact, flush eyes with water
    ●Stop use and ask a doctor if redness or iritation develop
    ●If swallowed contact a poison center

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Wipe over the skin or affected area, recommended for single use, dispose of used wipe in an approved manner.

  • Inactive ingredients

    INACTIVE INGREDIENTS: Chlorphenesin, Purified Water,
    Propylene Glycol

  • Package Label - Principal Display Panel

    1234

  • INGREDIENTS AND APPEARANCE
    70% ISOPROPYL ALCOHOL PREP PAD 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-963
    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
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-963-011 in 1 BAG12/30/2020
    12.33 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:51706-963-021 in 1 BAG12/30/2020
    20.238 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/30/2020
    Labeler - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhangzhou Zhongnan Nursing Products Co.,ltd416376835manufacture(51706-963)
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