Label: ELITE 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 April 1, 2021

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

  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand wipes to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use
    • in children less than 2 months of age
    • on open skin wounds

    When using this product  • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if
    • irritation and redness develop
    • condition persists for more than 72 hours

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

  • Directions

    • open the wipe sachet, stretch the wipe
    • wet hands thoroughly with product and allow to dry without wiping 
    • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    water, glycerin, aloe vera

  • Questions? +1-888-401-1003

    You may also report serious side effects to this phone number
    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    70% ALCOHOL

    ETHYL ALCOHOL ANTISEPTIC HAND SANITIZING WIPES

    Moisturizing with Aloe Vera

    100% FRESH UNTIL OPENED

    DISSIPATING ALCOHOL

    OUR WIPES 100%FRESH

    INDIVIDUAL PACKET

    Soft Individually Wrapped Sanitizing Wipes

    www.astro-us.com

    Manufactured for: Aksoylu Properties, 9705 Liberia Avenue, Unit 299, Manassas, Virginia 20110

    COUNTRY OF ORIGIN: TURKEY

    astro®

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ELITE WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81682-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81682-001-0210 in 1 BOX04/01/2021
    11 in 1 PACKET
    14 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:81682-001-0320 in 1 BOX04/01/2021
    21 in 1 PACKET
    24 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:81682-001-0450 in 1 BOX04/01/2021
    31 in 1 PACKET
    34 mL in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:81682-001-05100 in 1 BOX04/01/2021
    41 in 1 PACKET
    44 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:81682-001-06250 in 1 BOX04/01/2021
    51 in 1 PACKET
    54 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2021
    Labeler - PROKIM KAGITCILIK VE KIMYEVI MADDELER LIMITED SIRKETI (595754780)
    Establishment
    NameAddressID/FEIBusiness Operations
    PROKIM KAGITCILIK VE KIMYEVI MADDELER LIMITED SIRKETI595754780manufacture(81682-001)