Label: ASSURED - isopropyl alcohol patch 

  • NDC Code(s): 55310-001-01
  • Packager: SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Water

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  • ACTIVE INGREDIENT

    Active Ingredient

    Isopropyl Alcohol 70% v/v

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  • PURPOSE

    Purpose

    Antiseptic

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  • 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.

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  • 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

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  • WARNINGS

    Warnings

    For external use only

    Flammable. Keep away from fire or flame

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  • DOSAGE & ADMINISTRATION

    Directions

    Apply to skin as needed

    Discard after single use

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  • 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

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  • STOP USE

    Stop use and ask a doctor if

    -excessive irritation and redness develop

    -condition gets worse or persists for more than 7 days

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  • INGREDIENTS AND APPEARANCE
    ASSURED 
    isopropyl alcohol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55310-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL .70 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55310-001-01 300 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/04/2013
    Labeler - SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD. (530501535)
    Establishment
    Name Address ID/FEI Business Operations
    SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD. 530501535 manufacture(55310-001)
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