Label: ALCOHOL PREP PAD- isopropyl alcohol swab

  • 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 January 24, 2019

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  • ACTIVE INGREDIENT

    Isopropyl Alcohol 70%

  • PURPOSE

    Antiseptic

  • Keep out of reach of children

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

  • USE

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

  • WARNINGS

    For external use only.

    Stop and ask a doctor if irritation develops

  • DIRECTIONS

    • Apply topically as needed to cleanse intended area.
    • Discard after single use
  • INACTIVE INGREDIENT

    Purified Water

  • DRUG FACTS

    image

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70897-007-011 in 1 PACKET; Type 0: Not a Combination Product01/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/24/2019
    Labeler - Davemed Healthcare Co., Ltd (529128716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davemed Healthcare Co., Ltd529128716manufacture(70897-007)
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