Label: ANTIMICROBIAL SANITIZING HAND WIPE swab

  • 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 28, 2022

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic Handwash

  • Uses

    . For hand sanitizing to decrease bacteria on the skin.

    . Recommended for repeated use.

  • Warnings

    For External Use Only

    . Flammable.

    . Keep away from fire or flame.

    When using this product

    . Do not get into eyes.

    . In case of eye contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    irritation and redness develop.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other Information

    . Do not store above 110°F (43ºC).

    . May discolor certain fabrics or surfaces.

  • Inactive Ingredients

    Aloe Vera Leaf, Fragrance, Purified Water, Trolamine.

  • 1307 Antimicrobial Sanitizing Hand Wipe

    1307 BX MASTER1307 Antimicrobial Sanitizing Hand Wipe Label

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL SANITIZING HAND WIPE 
    antimicrobial sanitizing hand wipe swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-330-0110 in 1 CASE08/16/2020
    1NDC:67777-330-02100 in 1 BOX
    10.7 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/16/2020
    Labeler - Dynarex (008124539)
    Registrant - Dynarex (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Province Jianerkang Medical Dressing Co., Ltd.530968767manufacture(67777-330)
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