Label: ADVANCED ALCOHOL WIPES- ethyl 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 August 4, 2020

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

  • Drug Facts

  • Active ingredient[s]

    Ethyl alcohol 75% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use[s] for hand-washing to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • 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 this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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 hep or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.

    • 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 INGREDIENT

    Inactive ingredients Aloe Vera, Fragrance, PEG 40 Hydrogenated Castor Oil, Pure Water.

  • SPL UNCLASSIFIED SECTION

    Kill 99.99% of germs

    QUICK & EASY CLEANING

    75% ETHYL ALCOHOL

    NO PARABEN

    RINSE-FREE

    INSTRUCTIONS:

    1.Open the front lid and peel back the resealable sticker.

    2. Pull out each wipe as needed.

    3.Make sure to reseal the sticker and close the lid after every usage to keep the wipes moist.

    WHERE TO USE:

    AT WORK

    ON THE GO

    AT HOME

    Manufactured by:

    Ecowipes Vietnam Corp.

    No.3, An Phu Dong 25 St., Dist 12,

    Ho Chi Minh City, 70000 Vitenam.

    Distributed by:

    Rubicon Ventures L.L.C. dba Nimbus9

    West Springfield, MA 01089 USA.

    Made in Vietnam.

    AW75-80PO

  • Packaging

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ADVANCED ALCOHOL WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78898-375
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78898-375-8080 in 1 PACKET08/03/2020
    14.86 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2020
    Labeler - Eco Wipes Vietnam Corporation (557278721)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eco Wipes Vietnam Corporation557278721manufacture(78898-375)