Label: ALCOHOL-BASED DISINFECTANT HAND SANITIZER gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    74757-002-01, 74757-002-02, 74757-002-03, 74757-002-04, view more
    74757-002-05, 74757-002-06, 74757-002-07, 74757-002-08, 74757-002-09, 74757-002-10, 74757-002-11, 74757-002-12, 74757-002-13
  • Packager: GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD
  • 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 May 21, 2020

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

  • Active Ingredient(s)

    Ethyl Alcohol 75%

  • Purpose

    Antimicrobial

  • 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

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

  • STOP USE

    • In children less than 2 months of age
    • On open wounds

  • 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.

  • Directions

    • When using this product, do not use in
      or near the eyes. In case of contact, rinse
      eyes thoroughly with water. Stop using
      and ask doctor if irritation or rash appears
      and lasts. Keep out of reach of children.
      If swollowed, get medical help or contact a
      Poison Control Center immediately.
  • Other information

    • Other Information:
      • Store below 106° F (41° C)
      • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • USE

    • Place enough Product in your palm to thoroughly spread on both hands and rubinto the skin until dry.
    • Children under 6 years of age should be supervised when using this product see full prescribing information for label

  • Package Label - Principal Display Panel

    07021005000433010050108060309

  • INGREDIENTS AND APPEARANCE
    ALCOHOL-BASED DISINFECTANT HAND SANITIZER 
    alcohol-based disinfectant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74757-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74757-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:74757-002-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:74757-002-02330 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:74757-002-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:74757-002-05120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:74757-002-06236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:74757-002-07250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    8NDC:74757-002-08300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    9NDC:74757-002-091000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    10NDC:74757-002-102000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    11NDC:74757-002-113000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    12NDC:74757-002-124000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    13NDC:74757-002-135000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/20/2020
    Labeler - GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD (540725476)
    Registrant - GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD (540725476)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD540725476manufacture(74757-002)