Label: DISPOSABLE HAND SANITIZING- alcohol gel

  • 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 June 16, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol, 62% v/v

    Purpose

    Antiseptic

  • Use

    Decrease bacteria on hands

  • Warnings

    For external use only

    Flammable, keep away from fire or flame

    When using this product

    keep out of eyes.

    Discontinue use if 

    irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children

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

  • Directions

    Place a 'palmful of product in one hand. Spread on both hands and rub the skin until dry.

  • Other Information

    To report a serious adverse reaction please write to Added Extras,16# Yonghe Road, Beilun District, Ningbo City, Zhejiang Province,China

  • Inactive ingredients

    Aqua, Glycerin, carbomer, Triethanolamine, Fragrance.

  • Package Labeling: 76562-005-01

    Bottle

  • Package Labeling: 76562-005-02

    Bottle2

  • INGREDIENTS AND APPEARANCE
    DISPOSABLE HAND SANITIZING 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76562-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76562-005-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC:76562-005-0255 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - Ningbo Qiyu Commodity Co., Ltd. (554518486)
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