Label: ALCOHOL PREP PAD- isopropyl alcohol cloth

  • 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 May 20, 2021

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  • Drug Facts

    Active Ingredient:

    Isopropyl Alcohol 70% v/v

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Use: for preparation of the skin prior to injection.

  • WARNINGS

    Warnings:

    ■ For external use only. ■ Flammable. Keep away

    from fire or flame. ■ Do not use: with electrocautery

    procedures or in eyes. ■ Stop use: if redness or

    irritation develops, if condition continues for more than

    72 hours consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

    ■ Keep out of reach from children. If swallowed, get medical attention or

    call Poison Control Immediately.

  • DOSAGE & ADMINISTRATION

    Directions: Apply alcohol as needed to clean intended area.  Discard after single use.

  • INACTIVE INGREDIENT

    Inactive Ingredients: purified water.

  • Product Label

                                      NDC 81238-0008-1

    aramark

    ALCOHOL PREP PAD

    MEDIUM

    Sterile - Single Use - Latex Free

    Saturated with 70% v/v Isopropyl Alcohol

    1 Prep Pad [1.2 x 2.6 in. (3 x 6.5 cm)]

    Manufactured for Aramark  

    Lenexa, KS 66219

    Made in China

    0008-1

    res

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.70 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-0008-10.4 mL in 1 PACKET; Type 0: Not a Combination Product04/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/16/2021
    Labeler - Western First Aid Safety dba Aramark (043861524)
    Registrant - Western First Aid Safety dba Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(81238-0008)
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