Label: 75% ALCOHOL DISINFECTANT- alcohol liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    81191-001-01, 81191-001-02, 81191-001-03, 81191-001-04, view more
    81191-001-05, 81191-001-06, 81191-001-07, 81191-001-08, 81191-001-09, 81191-001-10, 81191-001-11, 81191-001-12, 81191-001-13, 81191-001-14, 81191-001-15, 81191-001-16, 81191-001-17, 81191-001-18, 81191-001-19, 81191-001-20
  • Packager: Zhongrong Technology Corporation 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 December 14, 2020

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

  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v. Purpose: Disinfection

  • Purpose

    Disinfection, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat and flame, Keep out of reach of children.

    Avoid contact with face, eyes and broken skin. If irritation occurs, seek medical advice.

  • 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

    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.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    purified water

  • Package Label - Principal Display Panel

    2500 mL NDC: 81191-001-15 2.5L

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL DISINFECTANT 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81191-001
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81191-001-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    2NDC:81191-001-0250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    3NDC:81191-001-0360 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    4NDC:81191-001-04100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    5NDC:81191-001-05150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    6NDC:81191-001-06200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    7NDC:81191-001-07236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    8NDC:81191-001-08240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    9NDC:81191-001-09300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    10NDC:81191-001-10500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    11NDC:81191-001-11600 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/26/2020
    12NDC:81191-001-121000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
    13NDC:81191-001-131500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
    14NDC:81191-001-142000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
    15NDC:81191-001-152500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
    16NDC:81191-001-163000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
    17NDC:81191-001-173780 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
    18NDC:81191-001-185000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
    19NDC:81191-001-19200000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
    20NDC:81191-001-201000000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/25/2020
    Labeler - Zhongrong Technology Corporation Ltd. (529575698)
    Registrant - Zhongrong Technology Corporation Ltd. (529575698)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhongrong Technology Corporation Ltd.529575698manufacture(81191-001) , label(81191-001)