Label: ANTIBACTERIAL HAND SANITIZER 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 October 19, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    ANTISEPTIC

  • Use

    TO DECREASE BACTERIA ON THE SKIN THET WOULD CAUSE DISEASE.RECOMMEND FOR REPEATED USE.

  • Warnings

    FOR EXTERNAL USE ONLY:HANDS.FLAMMABLE.KEEP AWAY FROM HEAT AND FLAME.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING THIS PRODUCT

    AVOID CONTACT WITH FACE,EYES ,AND BROKEN SKIN IN CASE OF EYE CONTACT,FLUSH WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE.

  • Stop use and ask a doctor if

    ALLERGY OR REDNESS DEVELOPS.

  • Keep out of reach of children

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

  • Directions

    WET HANDS THOROUGHLY WITH PRODUCT AND RUB INTO SKIN UNTIL DRY .CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED BY AN ADULT WHEN USING.

  • Other information

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

    CARBOMER,CHLOROXYLENOL,WATER,,GLYCERIN,TROLAMINE,PROPYLENE GLYCOL.

  • Package Label - Principal Display Panel

    75273-006-09 2ML2365003006030120266100

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    antibacterial hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75273-006
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75273-006-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    2NDC:75273-006-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    3NDC:75273-006-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    4NDC:75273-006-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    5NDC:75273-006-05236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    6NDC:75273-006-06266 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    7NDC:75273-006-07300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    8NDC:75273-006-08500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    9NDC:75273-006-092 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/15/2020
    Labeler - YIWU BAOLINA COSMETIC CO., LTD (528943389)
    Establishment
    NameAddressID/FEIBusiness Operations
    YIWU BAOLINA COSMETIC CO., LTD528943389manufacture(75273-006)
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