Label: ALCOHOL PREP PAD- isopropyl alcohol swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 19, 2022

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  • Active Ingredient

    Isopropyl Alcohol 70%v

    Purpose

    Antiseptic

  • Use

    For preparation of the skin prior to injection.

  • WARNINGS

    For External use only.

    Flammable,keep away from fire or flame.

    Do not use in the eyes,or on mucous membranes.

    Stop use and consult a doctor if irritation and redness develop,condition persists for more than 72 hours .

    keep out of reach of children

    In case of accidental ingestion, seek assistance or consult a Poison Control Center immediately.

  • Directions

    Wipe injection site vigorously and discard.

  • Inactive ingredients

    purified water

  • PRINCIPAL DISPLAY PANEL

    ruicheng

    section text here

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50232-001
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50232-001-015000 in 1 CONTAINER01/01/2018
    10.35 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:50232-001-0210000 in 1 CONTAINER01/01/2018
    20.35 mL in 1 POUCH; Type 0: Not a Combination Product
    3NDC:50232-001-033000 in 1 CONTAINER01/01/2018
    30.35 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34405/14/2012
    Labeler - BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD. (421285328)
    Establishment
    NameAddressID/FEIBusiness Operations
    BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD.421285328manufacture(50232-001)
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