Label: ALL CLEAN NATURAL SANITIZER 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 28, 2021

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol/ Alcool éthylique USP 80% v/v

  • Purpose

    Antiseptic

  • Use

    Antiseptic skin cleanser/Nettoyant antiseptique pour la peau

  • Warnings

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

    Do Not Use

    - On children less than 2 months of age

    - On open skin wounds

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

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    keep out of reach of children.

    If swallowed, get medical help 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 ingredients

    Purified water, Glycerin, Hydrogen Peroxide

  • SPL UNCLASSIFIED SECTION

    FRAGRANCE FREE

    *Close Cap After Use*

    NPN 80103441

    NDC 78806-101-50

    Manufactured By:

    All Clean Natural

    5310 1 St SW

    Calgary, AB T2H 0C8

    allcleannatural.com

    DIRECTIONS: For first use, remove lid. Thread wipe from center of roll through dispensing hole in the lid and pull wipe up and slightly downwards to the side. Snap lid securely shut. Remove cap and pull wipe to the side to dispense. Keep cap closed between uses to prevent moisture loss. Wipe hands, discard.

    WARNING: For external use only. Do not ingest. If ingested, drink plenty of water and contact poison control. Avoid contact with eyes. If contact occurs, flush thoroughly with water. If skin irritation occurs, discontinue use. Keep out of reach of children and pets. Children must be under adult supervision while using this product. This product contains 80% ethyl alcohol and may damage certain surfaces. Always test in an inconspicuous area first to ensure the surface will not be damaged. Not recommended for varnished, painted, or coated surfaces where other solvents may damage the finish. WHO Recommended Formula.

  • Packaging

    single pack800 wipes160 wipes450350270 Wipes270 Wipes110 Wipes

  • INGREDIENTS AND APPEARANCE
    ALL CLEAN NATURAL SANITIZER WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78806-101
    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)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78806-101-50270 in 1 CANISTER06/20/2020
    15 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:78806-101-60450 in 1 CANISTER06/26/2020
    25 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:78806-101-3090 in 1 CANISTER06/20/2020
    35 mL in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:78806-101-70160 in 1 CANISTER06/26/2020
    45 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:78806-101-80350 in 1 CANISTER06/26/2020
    55 mL in 1 PACKAGE; Type 0: Not a Combination Product
    6NDC:78806-101-40110 in 1 CANISTER06/20/2020
    65 mL in 1 PACKAGE; Type 0: Not a Combination Product
    7NDC:78806-101-90800 in 1 CANISTER06/20/2020
    75 mL in 1 PACKAGE; Type 0: Not a Combination Product
    8NDC:78806-101-1150 in 1 BAG06/20/2020
    8NDC:78806-101-015 mL in 1 PACKET; Type 0: Not a Combination Product
    9NDC:78806-101-015 mL in 1 PACKET; Type 0: Not a Combination Product05/03/2021
    10NDC:78806-101-21100 in 1 BAG06/20/2020
    10NDC:78806-101-015 mL in 1 PACKET; Type 0: Not a Combination Product
    11NDC:78806-101-311000 in 1 BOX06/20/2020
    11NDC:78806-101-015 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/20/2020
    Labeler - All Clean Natural Ltd (203593355)
    Establishment
    NameAddressID/FEIBusiness Operations
    All Clean Natural Ltd203593355manufacture(78806-101)
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