Label: STARCAP MEDICAL PRIVATE LIMITED- 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 June 7, 2014

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  • Active Ingredients

    Isopropyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use:

    For preparation of the skin prior to injection; to decrease germs in minor cuts and scrapes.

  • 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.


    Caution:

    Do not apply to irritated skin.


    Do not use

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


  • Directions:

    Wipe injection site vigorously.


  • Other information:

    Store at room temperature


  • Inactive ingredients:

    Water

  • Principal Display Panel

    StarCap Medical Pvt. Ltd.

    NDC 65003-018-02

    200 Individual Pads

    Alcohol Prep Pads

    Sterile Medium

    For Individual, Professional and Hospital Use

    Saturated with 70% v/v Isopropyl Alcohol for external use only

    Latex Free

    Sterile in unopened, undamaged package

    PIN DOT WOVEN

    uthylrfed.jpg


  • INGREDIENTS AND APPEARANCE
    STARCAP MEDICAL PRIVATE LIMITED  
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65003-018
    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:65003-018-021 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34406/07/2014
    Labeler - StarCap Medical Private Limited (650687176)
    Establishment
    NameAddressID/FEIBusiness Operations
    StarCap Medical Private Limited650687176manufacture(65003-018)
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