Label: BLUE UNITY ALCOHOL WIPES- alcohol wipes 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 July 22, 2020

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  • Active Ingredient

    Ethyl Alcohol 75% v/v

  • Purpose

    Ethyl Alcohol   Antiseptic

  • Use

    Helps reduce bacteria that potentially can cause disease.

  • 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

    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.

  • Directions

    • Open the package and wipe skin 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)
  • Manufactured by Wenzhou Guanshang Paper Co., Ltd

    Made in China

    Distributed by RIXI Group USA Inc
    8966 Mason Ave, Chatsworth, CA 91311
    Phone: (818)341-6600
    gary@rixiglobal.net

  • Inactive ingredients

    WATER

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BLUE UNITY ALCOHOL WIPES 
    alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78122-940
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78122-940-1010 in 1 PACKAGE; Type 0: Not a Combination Product06/15/2020
    2NDC:78122-940-5050 in 1 PACKAGE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2020
    Labeler - Wenzhou Guanshang Paper Co., Ltd (412940960)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wenzhou Guanshang Paper Co., Ltd412940960manufacture(78122-940)
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