Label: ANTIBIOTICOS HAND SANITIZER- 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 April 19, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients 

    Active ingredients: Ethyl alcohol 70.0% w/w

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Aloe Barbadensis Leaf Juice, Glycerin, Carbomer, Polysorbate 80, Triethanolamine , Flavor, Tocopheryl Acetate

  • Purpose

    Purpose: ANTISEPTIC

  • Warnings

    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

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

  • Uses

    Uses:

    To decrease bacteria on hands.

  • Directions

    Directions:

    Please take out adequate amounts of gel on palm of your hand and rub your hands for 15 seconds at least.

  • Other information

    Other information
    • Store between 15-30˚C (59-86˚F)
    • Avoid freezing and excessive heat above 40˚C (104˚F)

  • Questions

    Questions?
    www.cos-face.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    ANTIBIOTICOS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75008-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75008-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - COS-FACE Co., Ltd. (557831282)
    Registrant - COS-FACE Co., Ltd. (557831282)
    Establishment
    NameAddressID/FEIBusiness Operations
    COS-FACE Co., Ltd.557831282manufacture(75008-010)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!