Label: CVS POVIDONE IODINE- povidone iodine swab

  • NDC Code(s): 69842-935-01, 69842-935-10
  • Packager: CVS Pharmacy Inc
  • 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 July 13, 2020

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  • Active Ingredient

    Povidone-Iodine, 10% w/v

  • Purpose

    Antiseptic

  • Uses

    • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • longer than one week unless directed by a physician
    • on individuals who are allergic or sensitive to iodine
    • over large areas of the body

    Stop use and ask a doctor

    • irritation and redness develop
    • condition persists for more than 72 hours
    • in case of deep or puncture wounds, animal bites or serious burns

    Keep out of reach of children.

    If swallowed, seek medical assistance or immediately contact a Poison Control Center.

  • Directions

    • clean the affected area
    • apply a small amount of this product on the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    protect from freezing and avoid excessive heat

  • Inactive ingredients

    citric acid, disodium phosphate, purified water

  • Package Label

    Box Packaging

    packet label

  • INGREDIENTS AND APPEARANCE
    CVS POVIDONE IODINE 
    povidone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-935
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-935-1010 in 1 BOX09/01/2020
    1NDC:69842-935-016 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 finalpart333A09/01/2020
    Labeler - CVS Pharmacy Inc (062312574)