Label: ALCOHOL WET WIPE- alcohol liquid

  • 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 April 10, 2020

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  • SPL UNCLASSIFIED SECTION

    Alcohol prep pad

  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Wipe the surface of the object to sterilize and disinfect

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Wipe the surface of the object
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    purified water USP

  • Package Label - Principal Display Panel

    10 PCS/bag NDC: 75111-201-01

    50 PCS/bag NDC: 75111-201-02

    70 PCS/bag NDC: 75111-201-03

    80 PCS/bag NDC: 75111-201-04

    80 PCS/box NDC: 75111-201-05

    100 PCS/box NDC: 75111-201-06

    120 PCS/bag NDC: 75111-201-07

    123456

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WET WIPE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75111-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75111-201-0155 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:75111-201-02270 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:75111-201-03380 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    4NDC:75111-201-04430 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    5NDC:75111-201-05430 mL in 1 BOX; Type 0: Not a Combination Product03/30/2020
    6NDC:75111-201-06540 mL in 1 BOX; Type 0: Not a Combination Product03/30/2020
    7NDC:75111-201-07650 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Enping Jiaxin Daily Necessities Co., Ltd. (403010421)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enping Jiaxin Daily Necessities Co., Ltd.403010421manufacture(75111-201)
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