Label: ALCOHOL-BASED DISINFECTANT 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 July 10, 2020

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

  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

  • Purpose

    Purpose: Antimicrobial , Hand Sanitizer

  • Use

    Pour a suitable amount of gel onto the palm of your hand and rub hands together thoroughly. Gel will evaporate. No need to rinse or dry hands after use

  • Warnings

    Keep out of reach of children This product is highly flammable Keep away from open flame or fire Avoid contact with eyes and mucous membranes Harmful if swallowed

  • Do not use

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  • WHEN USING

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  • STOP USE

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  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    This product has a strong inhibitoryffect on various bacteria and virusesincluding Staphylococcus Aureus,

    Pseudomonas Aeruginosa, CandidaAlbcans and Escherichia Coli

  • Other information

    Keep in a cool, dry and well ventilated area away from direct sunlight

  • Inactive ingredients

    Water, Glycerin, Carbomer,Triethanolamine, Lavender Essence

  • Package Label - Principal Display Panel

    300300060120

    2362505001000200040005000

  • INGREDIENTS AND APPEARANCE
    ALCOHOL-BASED DISINFECTANT HAND SANITIZER 
    alcohol-based disinfectant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79606-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79606-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    2NDC:79606-002-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    3NDC:79606-002-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    4NDC:79606-002-02120 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    5NDC:79606-002-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    6NDC:79606-002-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    7NDC:79606-002-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    8NDC:79606-002-082000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    9NDC:79606-002-093000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    10NDC:79606-002-104000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    11NDC:79606-002-115000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/10/2020
    Labeler - Foshan Lang-Yeon Trade Limited Company (554537424)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD540725476manufacture(79606-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Lang-Yeon Trade Limited Company554537424label(79606-002)