Label: MOLECURE SKINCARE 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 November 6, 2020

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

  • Drug Facts

  • Active ingredient

    Ethyl Alcohol (80%) 

  • Purpose

    Hand Sanitizing

  • Uses

    - hand sanitizer to decrease bacteria on the skin

    - recommended for repeated use

  • Warnings

    Flammable, keep away from fire / flame For external use only

    Do NOT dispose in toilet to avoid clogging.

    Keep in cool place indoors avoid high temperature and direct sunlight. Do NOT throw on fire.

    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 cover of the wet wipes or seal the sticker. After use please close the wet wipes cover or seal the sticker to keep the wet wipes moist.

     adults and children 12 years and over Use as directed
     children 6 years to under 12 years Use as directed
     children under 6 years ask a doctor

  • Other information

    • do not store in direct sunlight

    • store at 20-25° C (68-77° F)

    • protect from excessive moisture

  • Inactive ingredients:

    water, glycerine

  • Questions: +19174151404

    "You may also report serious side effects to this phone number.

    (Mon-Fri 9:00 AM - 5:00 PM)"

  • SPL UNCLASSIFIED SECTION

    Sanitary Hand & Skin Wet Wipe

    allantoin

    coco glocoside

    WARNING

    After use please close the seal to prevent water evaporation. Discontinue use if there is any wound, redness, swelling or other discomfort. Wet wipes do not dissolve in water.

    PRODUCT FEATURES

    Super thick soft cotton touch for increased comfort. Reverse osmosis purified water removes impurities.

    Consignor:

    Molecure,

    Inc. 2 Park Ave., 20th Floor,

    New York, NY 10016

    ISO GMP

    PRODUCT INFORMATION

    Name of Commodity: Hand wipes

    Product Specification: 180mm x 180mm / 80 wipes. / Net Weight: 440g / Gross Weight: 460g.

    Manufacturer: AGRO GRUP TEKNOLOJI LTD. STI.

    Selimpasa Mah. 6093.sk. No: 86/1

    Silivri / Istanbul - Türkiye

    UBB Record Number: 0080856431

    Man. License No: 27527096

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    MOLECURE SKINCARE  ALCOHOL WIPES
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79781-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79781-216-0180 in 1 CANISTER11/06/2020
    14.20 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 finalpart333A11/06/2020
    Labeler - Molecule Koruyucu Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi (533147775)