Label: UNIVERSAL INSTANT HAND SANITIZER liquid

  • 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 17, 2020

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Uses

    Hand Sanitizer to help reduce bacteria on skin.

  • WARNINGS

    Flammable. Keep away from fire or flame.For external use only

  • When using this product

    When using this product,do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water Stop use and ask doctor if irritation or rash appears and lasts.

  • 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.

  • When using this product

    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.
    • Children under 6 years of age should be supervised when using this product
  • Other information

    • Store below 106F(41C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Purified Water(Aqua), Carbomer, Gluconate Glycerin, Triclosan, Honeysuckle.

  • Package Label - Principal Display Panel

    301184505460887300100500237

  • INGREDIENTS AND APPEARANCE
    UNIVERSAL INSTANT HAND SANITIZER 
    universal instant hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74034-005
    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
    GLUCONATE ION (UNII: W552L9Y4VZ)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74034-005-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    2NDC:74034-005-0354 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    3NDC:74034-005-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    4NDC:74034-005-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    5NDC:74034-005-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    6NDC:74034-005-06237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    7NDC:74034-005-07300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    8NDC:74034-005-08500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    9NDC:74034-005-09887 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    10NDC:74034-005-101183 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2020
    Labeler - Sichuan Rejoy Essence Biotechnology Co., Ltd (407046287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sichuan Rejoy Essence Biotechnology Co., Ltd407046287manufacture(74034-005)
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