Label: ASSURED- isopropyl alcohol patch

  • Category: HUMAN OTC DRUG LABEL

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 January 9, 2013

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  • INACTIVE INGREDIENT

    Inactive Ingredients:  Water

  • ACTIVE INGREDIENT

    Active Ingredient

    Isopropyl Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Uses

    First aid to help prevent the risk of infection in minor cuts, scrapes and burns

    For preparation of the skin prior to injection

  • WARNINGS

    Warnings

    For external use only

    Flammable. Keep away from fire or flame

  • DOSAGE & ADMINISTRATION

    Directions

    Apply to skin as needed

    Discard after single use

  • DO NOT USE

    Do not use

    -in contact with eyes or with mucous membranes

    -more than 7 days unless directed by a doctor

    -over large areas of the body

    -on deep or puncture wounds, animal bites or serious burns

  • STOP USE

    Stop use and ask a doctor if

    -excessive irritation and redness develop

    -condition gets worse or persists for more than 7 days

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    ASSURED 
    isopropyl alcohol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55310-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL.70 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55310-001-01300 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/04/2013
    Labeler - SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD. (530501535)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD.530501535manufacture(55310-001)
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