Label: ALCOHOL PREP PADS - STERILE- alcohol pads swab

  • 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 15, 2022

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  • Active Ingredient

    Active Ingredient Purpose

    Isopropyl Alcohol, 70% v/v Antiseptic

  • Use

    For preparation of skin prior to injection

  • Use

    For preparation of skin prior to injection

  • Warnings

    For External Use Only

    Flammable, keep away from fire and flame

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Do not use

    When irritation and redness develop

  • 1) in the eyes, 2) with irritated skin, 3) with electrocautery procedures, 4) on mucous membranes

    When irritation and redness develop

  • Ask a doctor if

    Irritation and redness condtions persist for more than 72 hours

  • Directions

    Wipe injection site vigorously and discard

  • Other information

    Store at room temperature (59~86degrees F)

  • Inactive ingredient

    Water

  • Drug Facts

    ECSI_Alcohol Pad_Pouch

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PADS - STERILE 
    alcohol pads swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71677-5036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 1 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71677-5036-32000 in 1 CASE12/20/2022
    1NDC:71677-5036-2200 in 1 BOX
    1NDC:71677-5036-10.7 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/20/2022
    Labeler - Essential Cares Supplies, Inc. (809399350)
    Registrant - Essential Cares Supplies, Inc. (809399350)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jianerkang Medical Dressing Co., LTD.530968767manufacture(71677-5036)