Label: ART NATURALS- hand sanitizing wipes, ethanol cloth

  • Category: HUMAN OTC DRUG LABEL

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 October 25, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Ethanol 75% Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Single use wipes to 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

    These wipes do not replace wipes used for medical procedures

  • WHEN USING

    If eye contact occurs flush eyes with water

  • STOP USE

    Stop use if irritation and redness develop. If condition continues, consult your health care practitioner

  • 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

    Unfold towelette, wipe hands, discard after use

  • Other information

    • Store at room Temperature 59-86F
  • Inactive ingredients

    Water

  • Package Label - Principal Display Panel

    50 pcs

    200 gr NDC: 81406-002-50

    Art Naturals 50 pcs

    Hand Sanitizing Wipes- 50 pcs
    NDC: 81406-002-50

    Hand Sanitizing Wipes- 50 pcs-200 gr

    NDC: 81406-002-50

    Hand Sanitizing 50 pcs

  • INGREDIENTS AND APPEARANCE
    ART NATURALS 
    hand sanitizing wipes, ethanol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81406-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 25 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81406-002-50200 g in 1 POUCH; Type 0: Not a Combination Product02/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/15/2021
    Labeler - SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI (366438166)
    Registrant - SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI (366438166)
    Establishment
    NameAddressID/FEIBusiness Operations
    SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI366438166manufacture(81406-002)
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