Label: PPE361 ALCOHOL WIPES 80 WITH ALOE VERA AND VITAMIN E- ethyl alcohol 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 September 25, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Ethyl Alcohol 75%

  • PURPOSE

    Antiseptic

  • USES

    Hand sanitizer to decrease bacteria on the skin.

  • 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 eyes 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 help or contact a Poison Control Center right away.

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

  • DIRECTIONS

    ■ Wet hands thoroughly. Allow to dry without wiping.

    ■ 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

    Water (Aqua), Propanediol, Carbomer, Triethanolamine, Fragrance, Aloe Barbadensis Extract, Vitamin E.

  • QUESTIONS OR COMMENTS?

    1-888-405-4442 or visit www.itech361.com

  • PPE361 ALCOHOL WIPES 80 WITH ALOE VERA AND VITAMIN E (NDC 74871-082-00)

    PPE361 SANITIZING WIPES WITH ALOE VERA AND VITAMIN E 80

  • INGREDIENTS AND APPEARANCE
    PPE361 ALCOHOL WIPES 80 WITH ALOE VERA AND VITAMIN E 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74871-082
    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)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74871-082-0080 in 1 PACKET09/25/2020
    11 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 finalpart333A09/25/2020
    Labeler - ITECH 361 LLC (859157377)
    Registrant - ITECH 361 LLC (859157377)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHUJI JIANHE PAPER CO LTD554529241manufacture(74871-082)
    Establishment
    NameAddressID/FEIBusiness Operations
    ITECH 361 LLC859157377pack(74871-082)
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